News & Analysis as of

Grace Period Pharmaceutical Industry

Verrill

A Last-Minute Gift – Prescription Drug Reporting Grace Period and Good Faith Relief

Verrill on

In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more

Hogan Lovells

Unapproved stem cell therapies remains a top FDA enforcement priority

Hogan Lovells on

Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

Hogan Lovells on

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Akerman LLP - Health Law Rx

DEA Tweaks, Walks Back Changes to Renewal Process

DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be...more

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