The second day of the Generic Drugs Forum provided a significant amount of new and rehashed data, including explanations and suggestions regarding certain application submission issues, including but certainly not limited to DMFs, data integrity and the ongoing nitrosamine saga. Here are a few of the helpful hints presented: When providing amendments to DMF, the […]
The FDA has finalized the Guidance for Industry titled Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (here). The final guidance is essentially the same as the draft of the same name issued on October 22, 2022 with the exception of minor editorial changes to increase clarity. The use of classic […]
Today, the Office of Generic Drugs announced the issuance of 98 Product-Specific Guidances (PSGs). The guidances can be accessed here. In an email announcing the availability of the newly issued guidances, the FDA said: “Today’s batch of 98 PSGs (31 New and 67 Revised) contains: 68 PSGs for products with no approved ANDAs (including 31 complex products) 46 PSGs […]
On Tuesday, the Association of Accessible Medicines (AAM) heralded the passage of the Q1/Q2 bill as a mechanism to speed certain generic drugs through the FDA approval system by making information on the qualitative and quantitative formulation of certain products available to generic manufacturers seeking approval a generic version of those products. AAM’s announcement here […]
In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application […]
Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I […]
The OGD got back to business right away after the government reopened by publishing the final guidance titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (here). The issue of changing pH-adjuster ingredients for the purposes of creating a generic formulation of […]
It is no small task to get a guidance document issued by the FDA in normal operating times but in the face of the longest government shutdown in history, the issuance of 76 PSGs (32 new and 44 revised) is nothing short of amazing. Yesterday, the FDA announced the new and revised guidance documents’ availability […]
In today’s pre-publication Federal Register notice (here), the FDA announced publication of 17 new product specific guidances (PSGs) and 58 revised PSGs. This is the first release of PSGs since the May 20, 2025 dump of 36 new and 15 revised PSGs. Not only is this good news for developers of generic drugs, release of the […]
An Association for Accessible Medicines release (here) reports that the AAM “thanked the House Energy and Commerce Committee for marking up Q1/Q2 legislation previously introduced by Representatives by Congressmen [sic] Dunn of Florida and Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.” […]
