It was on September 24, 1984 that Congress gave birth to the Drug Price Competition and Patent Term Restoration Act, also known today as Hatch-Waxman (at the time of the Act’s passage, it was called Waxman-Hatch because the Democrats were in power). For those of you who don’t remember or weren’t even born when Hatch-Waxman […]
Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]
Some of you have asked why we keep such a close eye on ANDA approval actions. It is a valid question. Knowing the importance of moving freight through the OGD comes from a combined 40+ years of experience, both in the OGD and in industry, and it is clear to me that this is the […]
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 […]
