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Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA's denial of authorization...

On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk).

In January 2023, Vanda Pharmaceuticals, Inc. (Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. FDA-2023-P-0313 and FDA-2023-P-0344) regarding its product Hetlioz (tasimelteon).

During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications, our thoughts turned to the principles...

The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies.

We were preparing this blogpost about FDA's draft guidance on "Remote Interactive Evaluations" when we learned something. A phone call to FDA requested information...

Just over two years ago, I wrote about the challenges with implementation of the contraceptive mandate in the Patient Protection and Affordable Care Act (ACA).

A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products.

On February 20, 2024, FDA issued a letter to the medical device industry (link) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions.

A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agency's approach to crediting one expert's testimony over that of another expert during an administrative hearing.

The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act...

On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled "Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies."

New Year's is often associated with baby New Year and with resolutions, which in a convoluted way got us thinking about post-approval pregnancy studies.

Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years...

As we reported back in January, Phibro Animal Health Corporation challenged FDA's decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease...

Last week, FDA published a Request for Information (RFI) (here) seeking input from the public on its efforts to "to identify and eliminate outdated or unnecessary regulations."

What do Gene Autry's Rudolph the Red-Nosed Reindeer and FDLI have in common? Both are celebrating their 75th anniversaries in 2024. While "The Singing Cowboy" Gene Autry was busy in Los Angeles...

Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition...