![](https://www.mintz.com/sites/default/files/styles/banner/public/media/images/2018-05-10/Viewpoint-Landing_FDA_Regulatory_Mintz.jpg?itok=3wudsvUs)
FDA Regulatory
Viewpoints
Filter by:
Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests
October 2, 2023 | Blog | By Joanne Hawana , Benjamin Zegarelli
It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or LDTs, had made it through internal regulatory review processes and would be published imminently in the Federal Register. The agency moved very quickly following the White House Office of Management and Budget’s clearance of the rule, which had occurred just two days prior, likely due to the high probability that the federal government was going to shut down on October 1 if Congress did not come to a budget agreement. That shutdown was narrowly averted over the weekend, but had it not been, the last significant publication of the Federal Register would have been on Tuesday, October 3.
Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?
June 2, 2022 | Blog | By Joanne Hawana
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 5, 2022 | Blog | By Joanne Hawana , Benjamin Zegarelli
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 5, 2022 | Blog | By Joanne Hawana , Benjamin Zegarelli
FDA Begins Modernizing its Resources and Implementing Over-The-Counter Monograph User Fee Requirements
October 14, 2021 | Blog | By Joanne Hawana
As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.
Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon?
July 13, 2021 | Blog | By Joanne Hawana , Benjamin Zegarelli
Webinar Recording: FDA in 2021: A Look Ahead
February 18, 2021 | Webinar | By Joanne Hawana , Anthony DeMaio
FDA in 2020: What a Year!
December 15, 2020 | Blog | By Benjamin Zegarelli
Beyond COVID: House Committee Advances Several FDA-Related Bills
July 23, 2020 | Blog | By Margaret Jewett
OTC Monograph Reform: Key Takeaways and What Industry Can Expect
June 10, 2020 | Blog | By Benjamin Zegarelli, Joanne Hawana
Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law
March 30, 2020 | Blog | By Joanne Hawana
The VALID Act, Aiming to Reform the Regulation of Diagnostic Products, Is Finally Introduced in Congress
March 12, 2020 | Blog
FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
February 3, 2020 | Blog
FDA User Fees: How Do They Work?
January 28, 2020 | Blog
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- False Claims Act
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Pharmacy Benefits and PBM Contracting
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Probate & Fiduciary Litigation
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- State Attorneys General
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Value-Based Care
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology