As consultants we have the privilege of assisting many clients with FDA communications on a variety of topics and working with them to support many different types of drug product applications. Through our work we often identify common themes or issues that our clients are facing and one of the biggest headaches for our ANDA […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
As Bob has previously blogged on the highlights from AAM day by day, let me take a moment to dive a bit deeper into one of the sessions. As an attendee of this meeting for several years, one of the best things about AAM’s GRx+Biosims is that sessions at this meeting often offer a mix […]
The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances. Now that we’ve all had more time to carefully read and absorb the updates in the […]
The last blog that we drafted on this topic, The Curious Case of the Late Cycle Amendment under GDUFA III, was posted last summer (here). As a quick refresher on what we covered, the GDUFA III Commitment Letter (here) included several new enhancements to the Generic Drug User Fee Program, one of which was the inclusion of […]
The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs. The CDER Small Business & Industry Assistance (SBIA) held a webinar titled Facilitating Generic Product Availability Through Product-Specific Guidances (PSGS) for 2024 on April 25th. The slides and recordings will soon be posted […]
The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator! It was even more difficult than usual […]
In Part 1, we focused on drafting the Controlled Correspondence and tips for formatting and presenting the correspondence, but, after submission, the CC must be accepted by the coordinator to be placement in the queue for review. The office has been very strict, perhaps rightly so, but there have been a few headscratchers too. Some examples […]
Of the many benefits that have come from the Generic Drug User Fee Act (GDUFA) over the years, one has been the addition of response times for the FDA to answer Controlled Correspondences (CCs) that were first negotiated under GDUFA II. The Agency issued an FDA CC guidance, which was finalized in December 2020. Having a […]
Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III. The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do. The changes made to promote transparency […]
