Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized, including with respect to advertising and promotion. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, biologics, regenerative medicine products, foods, cosmetics, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.
Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:
- Determining regulatory status of novel products;
- Pre-market and post-market requirements for various regulated products;
- Restrictions on advertising and product sampling;
- State licensing schemes for prescription drug manufacturers and distributors;
- Compliance with prescription drug compounding regulations;
- Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
- Advising on or preparing clients’ written submissions to FDA requests for comments or rulemaking activities;
- Requirements for importing and exporting regulated products; and
- Food safety and labeling advice for food, including dietary supplements and functional foods.
Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims.
As an FDA regulatory specialist, Joanne assists the Mintz corporate team by performing regulatory due diligence as part of potential mergers and acquisitions that involve regulated companies, and she often works in conjunction with the Firm’s intellectual property attorneys to ensure that patent and regulatory activities are strategically aligned. She also collaborates regularly with Mintz attorneys who negotiate royalty monetization transactions and who defend false advertising or product liability litigation brought against FDA-regulated businesses. Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.
Prior to joining Mintz, Joanne was an attorney in the food and drug practice in the DC office of another law firm.
Joanne is an editor of and frequent contributor to the firm's Health Care Viewpoints.
Experience
- Represented a diagnostic developer during an FDA investigation into its alleged distribution of an unauthorized test for COVID-19 and subsequent recall activities.
- Supported Mintz Corporate Team in negotiating and executing the sale of a client’s FDA Priority Review Voucher to another party for over $100 million.
- Negotiated the release of consumer goods by FDA on behalf of a retailer client following the agency’s erroneous conclusion that the shipments contained laser components that did not comply with U.S. law, thereby leading to their detention at the port of entry.
- Counseled a nationally recognized health system regarding the construction of advertising claims for various services involving regenerative medicine-based therapeutic procedures.
- Served as FDA specialist and regulatory team leader on a client’s complex bid for a bankrupt pharmaceutical company’s U.S. and European drug-related assets, including marketing authorizations and distribution permits.
- Handled regulatory due diligence and related contractual negotiations for two acquisitions of independent testing laboratories by a global client.
- Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
- Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secured Emergency Use Authorizations from FDA that allowed the test to be distributed and used in the United States.
- Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
- Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics. Also assists various companies that market non-prescription consumer products in structuring and implementing their Advertising Compliance Programs and ensuring ongoing risk mitigation in new promotional activities or when launching new products.
- Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the compliance obligations associated with this form of compounding business, including with respect to applicable COVID-19 enforcement discretion policies.
- Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
- Counseled a cosmetic company on its response to an FDA Warning Letter related to the use of drug claims to promote cosmetic products and then assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
- Represented an innovative beverage company with a national profile on FDA compliance issues, labeling, promotional activities, and distribution agreements.
viewpoints
Federal Appeals Court Affirms Lower Court Ruling: Drug Pricing Transparency Rule Exceeds HHS’s Regulatory Authority
June 18, 2020 | Blog | By Joanne Hawana
A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case, the United States Court of Appeals for the District of Columbia Circuit issued a decision on June 16, 2020 affirming the district court’s judgement that vacated the HHS Drug Pricing Disclosure Rule. This ruling is yet another example of a court invalidating the Drug Pricing Disclosure Rule, which sought to require drugmakers’ television advertisements to disclose the list prices of their prescription drug products.
Read more
OTC Monograph Reform: Key Takeaways and What Industry Can Expect
June 10, 2020 | Blog | By Benjamin Zegarelli, Joanne Hawana
On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph drugs. We previously blogged about the surprise addition of the OTC monograph reforms within the CARES Act. On May 29, 2020, the Office of Nonprescription Drugs within the Food and Drug Administration (FDA) held a webinar titled “Monograph Reform is Here!” (a recording of the webinar is available here), which included key highlights from the OTC monograph reform.
Read more
FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19
June 1, 2020 | Blog | By Joanne Hawana
We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud (see here and here). These agencies and their respective law enforcement efforts have yet to slow down and appear to have accelerated as greater coordination begins to take root. As of May 29, 2020, the U.S. Food and Drug Administration (FDA) has issued 64 warning letters to companies making claims about a product alleged to be a COVID cure, treatment, or preventative product, while the U.S. Federal Trade Commission (FTC) had issued many, many more than that. In some cases, these warning letters are joint letters that come from both government agencies, which is never a good sign. The FTC in particular is making announcements on a regular basis about large batches of warning letters being issued, such as this one from May 21 highlighting that 50 more marketers of fraudulent COVID-19 products had received such a missive from the FTC.
Read more
Not So Sweet: Failure to Timely Recall Contaminated Ice Cream Results in Major Consequences for Texas Manufacturer
May 11, 2020 | Blog | By Joanne Hawana, Cassandra Paolillo
Earlier this month, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made headlines in 2015, largely because it resulted in multiple cases of listeriosis and, tragically, three deaths. Aside from the obvious health-related consequences to the public and reputational harm to the nationally-known manufacturer of sweet treats, the basis for the various charges and causes of action related to the outbreak demonstrate the broad range of legal consequences, both civil and criminal, that can result from the failure to address food safety requirements and regulatory compliance more generally.
Read more
Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA
May 5, 2020 | Blog | By Joanne Hawana, Hope Foster
Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.
Read more
COVID-19 and Lab Testing: What’s the Story Behind the Story?
April 29, 2020 | Blog | By Hope Foster, Joanne Hawana
Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these stories have told a mixed tale. The Washington Post and The New York Times both ran front page stories on April 19, 2020 about how the Centers for Disease Control and Prevention (CDC) had bungled production of the first U.S. test kits for detecting the presence of the novel coronavirus by manufacturing them in a lab contaminated with the virus, according to the Food and Drug Administration (FDA). The FDA, which regulates test kits, testing materials, and testing instruments, had investigated the causes of its sister agency’s failure, which delayed by weeks the nation’s fight against the virus.
Only days before those stories ran, news outlets reported that Great Britain had paid $20 million to purchase antibody tests from China but, upon their arrival in Great Britain, those tests were found not to work. On April 26, 2020, the front page story in The New York Times headlined that “Testing Remains Scarce as States Weigh Reopening.”
Day after day, we have read conflicting stories about lab testing: do we have sufficient capacity and capability or do we not? If we do not, why don’t we? We have seen an alphabet soup of federal agencies named as being involved with clinical labs and working towards a solution to the many issues that have been raised. Having worked with labs for decades, we thought we would explore these really important questions. Which agency is responsible for what, and what are they doing? Every day we receive questions like these, and we thought that we would share what we have learned.
Read more
Only days before those stories ran, news outlets reported that Great Britain had paid $20 million to purchase antibody tests from China but, upon their arrival in Great Britain, those tests were found not to work. On April 26, 2020, the front page story in The New York Times headlined that “Testing Remains Scarce as States Weigh Reopening.”
Day after day, we have read conflicting stories about lab testing: do we have sufficient capacity and capability or do we not? If we do not, why don’t we? We have seen an alphabet soup of federal agencies named as being involved with clinical labs and working towards a solution to the many issues that have been raised. Having worked with labs for decades, we thought we would explore these really important questions. Which agency is responsible for what, and what are they doing? Every day we receive questions like these, and we thought that we would share what we have learned.
FDA Continues Its Diverse Agency Actions in Response to COVID-19 Pandemic
April 22, 2020 | Blog | By Joanne Hawana
Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting much-needed medical products into the hands of health care providers on the frontlines of the pandemic as it hits the United States hard. We’ve already covered recent FDA policy changes aimed at expanding the availability of face masks, face shields, and respirators (see prior post here), so today’s post will focus on other emergency actions outside of the personal protective equipment space. Mintz clinical laboratory experts are also preparing separate articles on the diagnostic and antibody testing issues ongoing with the COVID-19 response, so we are not going to discuss testing in today’s post either.
Read more
And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19 Pandemic
April 6, 2020 | Blog | By Joanne Hawana
We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public health emergency. At the same time, however, the agency has also been taking various steps to help medical product sponsors and consumer product manufacturers and distributors prioritize their ongoing regulatory compliance activities during this challenging period for business-as-usual.
As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
Read more
As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law
March 30, 2020 | Blog | By Joanne Hawana
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020. The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously.
Read more
Public Safety and Fraud During the COVID-19 Outbreak: Will Congress Take Action?
March 25, 2020 | Blog
Yesterday, we blogged on how scammers are trying to monetize on the COVID-19 health crisis for their personal gain. Though the U.S. Food & Drug Administration (FDA) issued a consumer update yesterday saying that there is still no approved vaccine or drug to prevent or treat this disease, companies have continued to market products that claim to prevent, treat, or even cure COVID-19 in an attempt to “help” or profit from distressed, vulnerable Americans. While the FDA is working tirelessly to review possible vaccines, treatments, and cures, Americans should avoid endangering their health or lives by self-medicating. Per the FDA, self-medicating with any new product on the shelf (real or virtual) could not only lead to adverse effects but also could interfere with crucial medications. We are closely monitoring whether Congress will take specific actions on these increasingly prevalent issues in the context of the COVID-19 pandemic.
Read more
News & Press
A Mintz team led by Richard Gervase, Member and Chair of the firm’s Royalty & Revenue Interest Financing Transactions Group, advised global investment firm Sixth Street in a non-dilutive, senior secured credit facility of up to $475 million for Apellis Pharmaceuticals. Apellis received $375 million in funding at close, with ability to access an additional $100 million under the facility at the Company’s option prior to September 2025, subject to the satisfaction of certain conditions.
TikToker Drug Ads Spark Demands for FDA to Clarify Its Authority
February 16, 2024
Bloomberg Law spoke to Member Joanne Hawana in an article seeking clarity on the FDA’s authority over social media influencers promoting prescription drugs without clear warning risks.
Digging Into The Debate On FDA's Proposed Lab Test Rule
January 3, 2024
TikTokers Put Consumers at Risk as Drug Ads Go Unchecked by FDA
December 14, 2023
Member Joanne Hawana was quoted in a Bloomberg Law article discussing how TikTokers put consumers at risk of misinformation as drug ads go unchecked by the FDA. Joanne comments on the Office of Prescription Drug Promotion’s efforts to conduct research projects to better comprehend how viewers understand information presented in direct-to-consumer advertising.
Mintz is pleased to announce that Member Joanne Hawana has been awarded the Pro Bono Advocate of the Year Award by Kids In Need of Defense (KIND) for her exceptional contributions to her clients’ cases. The annual awards “recognize outstanding attorneys and volunteers who have gone above and beyond in their assistance to unaccompanied children.”
Mintz Forms Pioneering Women’s Health & Technology Practice
March 09, 2023
Mintz’s new Women’s Health and Technology Practice brings together attorneys from our transactional, intellectual property, health care, FDA regulatory, and litigation teams to serve FemTech and other life sciences clients. The practice advises companies, entrepreneurs, and investors focused on addressing unmet needs in women’s health.
Mintz Debuts 'Femtech' Practice For Life Science Clients
March 9, 2023
Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen Janos, Joanne Hawana, Karen Lovitch, and Melanie Levy.
MoCRA- Industry Must Prepare For Mandatory Adverse Event Reporting And Safety Substantiation Now: Expert
January 11, 2023
Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.
Pared-Down FDA-Fee Bill Moving With CR
September 28, 2022
Mintz Member Joanne Hawana was quoted in the National Journal discussing Congress' plan to reauthorize key user-fee programs that fund the Food and Drug Administration.
Charting A Year Of The Biggest COVID Scams Cited By FDA
March 15, 2021
Mintz Member Joanne S. Hawana was quoted in an analysis article published by Law360 on the biggest COVID-19 product scams and actions taken by the U.S. Food and Drug Administration (FDA) to tackle fraudsters during the ongoing crisis.
Mintz Advises NexImmune in its Upsized $126.5 Million IPO
February 17, 2021
Legal Risks of Employer-Sponsored Covid-19 Workplace Vaccination Clinics
February 12, 2021
Mintz Members Brian P. Dunphy, Joanne S. Hawana, and Jennifer B. Rubin co-authored a Bloomberg Law insights column examining potential legal liabilities for employers implementing Covid-19 workplace vaccination programs, explaining that immunity under the federal Public Readiness and Emergency Preparedness Act (PREP Act) is not absolute.
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020
An article published by Inside Health Policy featured extensive commentary from Senior Director of ML Strategies Aaron Josephson on priorities for the Senate Health, Education, Labor and Pensions (HELP) Committee following the 2020 Presidential election. Mintz Member Joanne Hawana was also quoted in the article.
COVID-19: Regulators Confronted with Scourge of ‘Fake Cures’
September 29, 2020
Mintz Member Joanne Hawana was quoted extensively in an article published by the International Bar Association on how consumer protection bodies, including the U.S. Food and Drug Administration, are dealing with the proliferation of fake products and treatments related to COVID-19.
Introduction to the Due Diligence Process
July 27, 2020
Mintz Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States
June 12, 2020
In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
Mintz Member Joanne Hawana is quoted in an article published by MedCity News discussing the latest decision by the U.S. Food and Drug Administration (FDA) granting an emergency use authorization for hydroxychloroquine and chloroquine for COVID-19, and the balance the agency is taking with the current pandemic.
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
Mintz Member Joanne Hawana, Senior Director of ML Strategies Aaron Josephson, and Mintz Associate Benjamin Zegarelli co-authored an article published in Law360 discussing the latest actions from the U.S. Food and Drug Administration (FDA) in response to COVID-19.
Mintz Promotes Eleven Attorneys to Member
May 10, 2019
FDA Finally Hitting Sweet Spot With Off-Label Oversight
November 21, 2018
This Law360 analysis piece looks at how the U.S. Food and Drug Administration (FDA) is easing concerns about off-label marketing restrictions without antagonizing the plaintiffs bar or public health advocates. FDA attorney Joanne Hawana is quoted providing third-party commentary in the piece.
MODERN Labeling Act Needs Liability Protection for Generics
November 14, 2018
This piece looks at what could make the proposed Making Objective Drug Evidence Revisions for New Modern Labeling (MODERN) Act stronger - primarily liability protection for generics. Joanne Hawana is among the FDA industry sources quoted providing commentary in the piece.
Cosmetic Companies Must Plan For New Regulation
December 14, 2017
Arameh O’Boyle, a Member and Nada Shamonki, Of Counsel in the Mintz Los Angeles office, and Joanne Hawana, Of Counsel in the firm’s Washington, DC office collaborated on an article published in Law360 on regulatory changes to the cosmetics and personal care products industries.
But What About Food? FDA Director Scott Gottlieb’s 4-month Scorecard
September 14, 2017
Mintz attorney Joanne Hawana authored an article published by ICIX assessing the performance of FDA Commissioner Scott Gottlieb’s first four months on the job.
Mintz Attorney Says New FDA Organizational Changes Could Have Big Food Industry Effects
July 5, 2017
The Food and Drug Administration quietly announced and enacted significant organizational changes. FDA and Health Law attorney Joanne Hawana is quoted in this article discussing the potential impacts of these changes could include faster FDA factory inspections and audits.
5 Ways Trump Could Change Food Safety Compliance
April 26, 2017
Joanne Hawana, an attorney in Mintz’s FDA and Fraud & Abuse, Compliance & Regulatory Counseling Practices, is included in this piece which discusses changes the Trump administration could make to Food Safety Compliance and the dangers of lawsuits against the government amid deregulatory efforts.
New FDA Enforcement Stats Show Shifting Targets
February 13, 2017
Health Law and FDA attorneys Bethany Hills and Joanne Hawana are among the industry sources quoted in this piece analyzing new statistics from the U.S. Food and Drug Administration showing a relatively quiet 2016, but a busier year for enforcement in 2017.
Will FDA Adverse Event Data Release Mean More Lawsuits?
January 18, 2017
In this Law360 feature article, Joanne Hawana and Dan Herling discuss the release of data regarding adverse events received by the FDA’s Center for Food Safety and Applied Nutrition, whether the timing of the release matters, and what greater AER transparency means for litigations risks.
The FDA targeted DTC, video, unapproved drug promotion in 2016
January 18, 2017
This article, published in Medical Marketing & Media, addresses the FDA’s new approach to regulating drugmakers’ advertising and promotion. Mintz FDA team members Bethany Hills and Joanne Hawana offer insight.
FDA Sticks to Its Naming Plan for Biologics and Biosimilars
January 13, 2017
This Bloomberg BNA Health Law article discusses the FDA's controversial guidance on the naming of biological products, designed to prevent inadvertent substitution and support safety monitoring when they are on the market.
Health Care Enforcement Review And 2017 Outlook: Part 1
January 13, 2017
Three attorneys from Mintz authored the initial installment of a four-part series recapping key government policies, regulations, and enforcement actions from 2016 and discussing their potential impacts on 2017.
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing & Media article on the FDA off-label hearing. The article discusses possible results from the hearing which could facilitate a regulatory resolution to the off-label pharmaceutical promotion issue.
Mintz Attorney Joanne S. Hawana to Speak at 2016 TEDCO Entrepreneur Expo
November 02, 2016
Joanne S. Hawana, Of Counsel for Mintz's Health Law Practice, is participating in two sessions at the 2016 TEDCO Entrepreneur Expo. The event will bring together entrepreneurs, business executives, investors, economic development officials, and legislators.
Why FSMA collaboration is the new normal in food transportation
November 1, 2016
FDA and Health Law attorney Joanne Hawana is quoted in this Refrigerated and Frozen Foods article on why frozen food manufacturers and grocery retails must remain diligent about checking that their safety procedures and policies still comply with best practices.
Providers, Pharmacists Call for Earlier FDA Guidance on Biosimilars
October 24, 2016
FDA and Health Law attorney Joanne Hawana is quoted in this Bloomberg BNA Health Care Policy Report article on how pharmacists and medical providers are calling upon the FDA for quick guidance on biosimilars.
Food Safety Regulations Will Affect California Tort Law
July 13, 2016
Dan Herling, a Litigation Member in the Mintz San Francisco office, and FDA attorney Joanne Hawana authored this San Francisco Daily Journal article covering the predicted impact of the FDA's food safety regulations on California tort law.
GE Salmon Sets Stage For Future GMO Labeling Regime
June 27, 2016
Health Law attorney Joanne Hawana and Associate Benjamin Zegarelli authored a Law360 column on how the Senate Appropriations Committee’s approval of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2017 appropriations bill sets the stage for GMO legislation.
Food Companies Are Hedging Their Bets With GMO Labeling
April 25, 2016
FDA and Health Law attorney Joanne Hawana and New York Associate Benjamin Zegarelli authored this Law360 column discussing the growing public support for genetically modified organism and genetic engineering labeling on appropriate food products across the board.
The Parental Drug Association (PDA) has published a book by Washington, D.C. FDA and Health Law attorney Joanne Hawana. According to the PDA, the book “presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions.”
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing and Media article on how despite calls for change from pharmaceutical marketers, it is not likely that limitations on direct-to-consumer practices will become a reality.
Events & Speaking
Speaker
Speaker
Speaker
Mar
12
2024
Drug Information Association (DIA): Advertising and Promotion Regulatory Affairs Conference
Sheraton Pentagon City Hotel Arlington, VA
Panelist
Panelist
Nov
10
2022
Guide to Advertising for Life Sciences Companies: Insights from Legal and Business Perspectives
Association of Corporate Counsel San Francisco
Online Event
Speaker
Sep
27
2022
The Food and Drug Administration (FDA): Series Spanning Key Topics
Regulation of Foods & Cosmetics
Speaker
May
26
2022
US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professionals Society (RAPS)
Moderator
Mar
8
2022
DIA Advertising and Promotion Regulatory Affairs Conference
Drug Information Association (DIA)
Arlington, VA
Speaker
Speaker
Oct
25
2021
Pro Bono in a Virtual Age: A conversation with KIND, Legal Aid Society, and Bread for the City
Kids In Need Of Defense (KIND)
Online Event
Speaker
Jun
17
2021
US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professional Society (RAPS)
Online Event
Panelist
Jun
8
2021
Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies
Food and Drug Law Institute
Online Event
Moderator
Speaker
Jan
15
2021
Mandatory or Voluntary Workplace Vaccination – Guidance for Employers
This is an online event.
Oct
8
2020
Food and Drug Law Institute Annual Conference
FDA’s Amended Intended Use Regulation – Has It Finally Hit the Sweet Spot?
Online Event
May
18
2020
DIA Advertising and Promotion Regulatory Affairs Conference
Engaging with Patients to Diversify Advertising and Promotional Activities
Online Event
Speaker
Apr
7
2020
Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording
Mar
31
2020
Introduction to Biologics and Biosimilars Law and Regulation Course Presented by FDLI
Regenerative Medicine Advanced Therapies (RMATs)
Jan
15
2020
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Panelist
Sep
24
2019
Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities
Mintz, 3580 Carmel Mountain Road | Suite 300, San Diego, CA
Speaker
Jun
20
2019
RAPS Virtual Program: US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2-Part Series)
Navigating Federal Trade Commission (FTC) Requirements for Medical Products
Moderator
May
3
2019
Food and Drug Law Institute Annual Conference
Regenerative Medicine, Gene Therapies, and FDA Regulation
Washington, DC
Speaker
Speaker
Speaker
Feb
6
2019
FDLI's Introduction to Drug Law and Regulation Course
Regulation of Over-the-Counter OTC Drugs
Lake County, Illinois
Speaker
Jan
16
2019
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Moderator
Nov
13
2018
Drug Compounding Post-DQSA: Emerging Regulatory Challenges & Business Opportunities
Mintz, One Financial Center, 38A, Boston, MA 02111
Speaker
Nov
6
2018
The 9th Annual Advertising and Promotion of Medical Devices Conference
FTC’s Authority Applied to the Regulation of Medical Devices
The Madison Hotel, Washington, D.C.
Moderator
Speaker
Faculty
Moderator
Speaker
Panelist
Speaker
Nov
10
2016
Speaker
Aug
9
2016
Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance
FDANEWS
Webinar
Speaker
Panelist
Read less
Aug
5
2015
Publications
- Co-author, The Grocer Will Fill Your Order Now: Modernizing Online Food Shopping Becomes a Priority for Federal Agencies, Update Magazine (Fall 2023).
Recognition & Awards
William P. Cunningham Award for Achievement and Service to the School of Law, University of Maryland (2007)
Manuscripts Editor, The Journal of Health Care Law and Policy (Vol. 10)
Recognized by The Legal 500 United States for Healthcare: Service Providers (2020)
Recognized by The Legal 500 United States for Healthcare: Life Sciences (2021)
JD Supra: Top Author, Readers' Choice Awards – Life Sciences (2021)
Pro Bono Advocate of the Year Award, Kids In Need of Defense (KIND) (2023)
Involvement
- Member, Food and Drug Law Institute (FDLI)
- Member, FDLI Publications and Academic Programs Committee
- Member, Drug Information Association (DIA)
- Member, American Bar Association (ABA), and ABA Health Law Section
- Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
- Member, FDLI Audit Committee
- Member, Mintz Pro Bono Committee
- Past Chair, FDLI Publications Committee
- Past Chair, FDLI Primer Committee
- Past Chair, FDLI Update Magazine Editorial Advisory Board
Recent Insights
A Mintz team led by Richard Gervase, Member and Chair of the firm’s Royalty & Revenue Interest Financing Transactions Group, advised global investment firm Sixth Street in a non-dilutive, senior secured credit facility of up to $475 million for Apellis Pharmaceuticals. Apellis received $375 million in funding at close, with ability to access an additional $100 million under the facility at the Company’s option prior to September 2025, subject to the satisfaction of certain conditions.
