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 […]
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 […]
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 […]
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 […]
