U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
Today, the FDA issued a new immediately effective guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that replaces the initial guidance by the same name that was issued on February 24, 2021. The new guidance can be found here. The industry has been awaiting the issuance of this revised guidance and the “FDA made […]
Hard to believe that it’s August 20, 2024 already, with just a little over one month until the end of the FDA’s 2024 Fiscal Year (FY). Time flies when you’re having fun! For today’s peek at approvals, I’m only reporting those through August 15th to increase the accuracy of the figures as the OGD is […]
Although the FDA’s regulatory requirements for acceptance of vendor test results in lieu of testing is clearly specified in 21 CFR 211.84 for incoming raw materials and container closures, the FDA has not put forth specific regulations for the acceptance of single-use consumables. Biologics manufacturers may use dozens or even hundreds of different single-use consumables […]
We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance […]
Visit with Lachman Consultants at Booth #314 during the event. We hope you’ll be joining us at the annual PAD/FDA Joint Regulatory Conference on September 9th-11th at The Westin Washington, DC Downtown. This years can not miss event is entitled Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity,” and will provide in-depth knowledge […]
It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75. (As a reminder, at mid-month, the OGD had […]
The FDA announced the Animal Drug User Fees (here) as well as the Animal Generic Drug User Fees (here). Unlike the Animal Drug User Fees for FY 2025, which are all are decreasing, the Animal Generic Drug User Fees are all increasing for FY 2025 with exception of the Generic New Animal Drug Product Fee, […]
Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and […]
In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves […]
