Opening remarks from John Murphy III, CEO and President of the Association for Accessible Medicines (AAM) started the GRx+Biosims conference today, and in these remarks, he noted the importance of generics and biosimilars in lowering the cost of prescription drugs and describing the progress of the AAM in that accomplishment. We heard from John Brooks, […]
FDA requires registration of facilities for everything from animal/veterinary and human drugs, medical devices, cosmetics, food, tobacco, radiation-emitting products, and vaccines, blood, and biologics. This blog focuses on the Drug Establishment Registration (DER) requirements. On September 25, 2026, a whirlwind of emails came through to those of us in the pharmaceutical world proclaiming that the […]
Yesterday, the FDA provided the 2027 science and research initiatives which were determined in collaboration with industry and the public, including feedback received during the FY 2026 Generic Drug Science and Research Initiatives Public Workshop. Each year through the GDUFA program, FDA identifies areas of research that address important and challenging scientific issues for “critical […]
After months of negotiations, the FDA published a proposed Commitment Letter for GDUFA IV, which will outline the OGD and Industry’s agreements regarding all aspects of the ANDA review and approval process. The proposed commitment letter can be found here. The 48-page document addresses all issues that have undergone negotiations regarding the proposed new iteration […]
The Official Generic Drug Monthly Statistical report has issued (here) and is in a new format. As of this morning (August 5), the charts for the June data have not been updated; however, if you scroll down to the “Download Monthly and Quarterly Activities Dataset” button you can find the data metrics for June. Let’s […]
Usually, every quarter, the FDA issues a series of new and revised product specific bioequivalence guidances designed to provide the industry with FDA’s current thinking on the appropriate methods to establish bioequivalence of certain products. Today, FDA issued a list (here) composed of only newly revised guidances and all of them are for injectable peptide […]
Everyone in the generic drug industry was shocked by the announcement that President Trump will impose 100% tariffs in 2028 and then increase them to 200% the year after for companies that do not onshore generic production. What does this mean? Unfortunately, we won’t know for a while as there are no details regarding the […]
With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]
In this morning’s Federal Register pre-notification page (here), the FDA announced the addition of 23 new Product-Specific Guidances (PSGs) and 48 revised PSG documents. The FDA began publishing PSGs on June 11, 2010 when it announced its first group of PSGs to assist firms in understanding the FDA’s current thinking on the bioequivalence requirements for specific […]
