The FDA has been walking a thin line on orphan drug exclusivity (ODE) ever since a September 30, 2021, ruling by the U.S. Court of Appeals for the Eleventh Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst), 14 F.4th 1299 (11th Cir. 2021). in the pre-publication of today’s Federal Register, the FDA […]
Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]
Seemingly every day, there is news of a dietary supplement (DS) running afoul of regulations, either by containing a hidden drug ingredient or claiming the product is used in the cure, mitigation, or treatment of a disease, running afoul of the existing FDA dietary supplement regulations. Congress had the opportunity to redefine FDA oversight of […]
Whether it be the supply chain, compliance issues, manufacturing issues, issues with packaging components, or just plain bad luck, the number of drug shortages continues to plague the pharmaceutical industry both domestically and overseas. The FDA current shortage list (here) contains 191 entries and, of that number, only 66 have been resolved, leaving 125 drug […]
Well, as we predicted in an earlier post in December (here), it was postulated that the month would not be a great month for approval actions. However, OGD did issue 25 approval actions in the last nine business days of December and ended the month unofficially with 52 full approval actions and 7 tentative approval […]
The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs. This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC. “This guidance provides information regarding the […]
It’s that time of the year again. We max out our credit cards, drink eggnog, bake cookies, revel with family and friends, and look back on the year that just passed. We hope you had a great year, and hope that the holiday season provides warmth and good tidings to all and the New Year […]
Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions. That is a total of (obviously) thirty‑one approval actions. Given that number, if the OGD could double its approval output by the end of the month, that would […]
Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]
The FDA has revised the guidance, originally issued in July 2022, titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (here) to include additional information as required relative to the performance goals outlined in the commitment letter for GDUFA III. While there aren’t many changes in the revision, it is certainly […]
