With the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward in its previously stated commitments to transparency. FDA has framed this initiative as a way to assist drug developers in learning from prior deficiencies, to ensure that
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Marketing Medical Devices: Navigating Increased FDA Scrutiny
By Morgan Lewis
With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of more than 100 “cease and desist” letters, the agency has demonstrated it believes that DTC…
FDA Announces Crackdown on DTC Advertising: What It Means for Pharma and What Comes Next
By Morgan Lewis
The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA) and its rules governing direct-to-consumer (DTC) prescription…
Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?
By Morgan Lewis
On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental biologics license application for the vaccine product, due in part to subsequent VAERS reports of “chikungunya-like illness” in relatively healthy…
A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs
By Morgan Lewis
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured, incremental approach to innovation. The FDA docket is open until October 3 for comments.
DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations
By Morgan Lewis
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The cybersecurity framework, typically seen in other industries such as defense contracting, serves as a warning to companies in the life sciences, medtech, and digital health…
FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests
By Morgan Lewis
The US Food and Drug Administration recently announced the launch of a regulatory incentive pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors that align their development activities with specific US national interests.
Orphan Drugs, Big Breaks: The Quiet Carve-Out in the ‘One Big Beautiful Bill Act’
By Morgan Lewis
The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be insulated from consideration in Medicare drug price negotiations. By redefining the qualifications for negotiation eligibility, the…
FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?
By Morgan Lewis
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025 FDA compiled and released more than 200 CRLs issued between 2020 and 2024 for approved new drug application (NDA) and biologics license…
Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference
By Morgan Lewis
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an overview of FDA’s approach to predetermined change control plans (PCCPs) and its draft guidance on pre-market submission requirements…