In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]
ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]
Today, the OGD published a list of 29 new Product-Specific Guidances (PSGs) and 33 revisions to existing PSGs, all of which have been added since February 15, 2024. The listing can be found here. This publication is different than the one we wrote about in another blog today regarding the FDA’s plans for issuance of new […]
Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections: Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024) Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024) Section 1 contains a list […]
Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions. Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received. The OGD officially issued 53 approval actions in […]
If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages. The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well. With different individuals providing […]
At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals. The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals. Here are some of the points […]
Doug Long has become a fixture at AAM meetings, providing invaluable data on the drug industry on behalf of his employer, IQVIA. This presentation is always the highlight of AAM annual meetings. All attendees at this meeting make sure to have their seats nice and early to hear his state of the generic and biosimilars […]
At yesterday’s AAM annual meeting, David Gaugh, AAM’s interim President and CEO, discussed the unprecedented events that threaten the sustainability of today’s generic drug and biosimilar industry. In his keynote address, he addressed how the generic drug and biosimilar industry is being stressed by economic issues, PBMs, government programs, and other events out of its […]
January 2024 approval actions show that the FDA is moving in the right direction. The OGD unofficially issued 55 full-approval actions as well as 19 tentative approval actions for a total of 74 approval actions, a significant jump from December’s unofficial total of 59 total approval actions (52 full and 7 tentative). We are waiting […]
