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Now That the ANDA is Approved…What Do We Do with It?

On the last day of at the Association for Accessible Medicines GRx-Biosims conference in Bethesda, members of the FDA joined industry for an informative and interactive discussion on post-approval supplements.  Dr. Paul Schwartz and his colleague Olugbenga Okubadejo expressed satisfaction with the current state of the post-approval supplement process, as well as the example of teamwork it has taken to get it there (both within the FDA and also in partnership with industry).  

Audience Perspective – Both Sides of the Controlled Correspondence Story; One Common Problem

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, members of the FDA and industry came together to present opinions and discuss the Controlled Correspondence process.  Controlled Correspondence (CC) between the FDA and industry is very much like an important pen pal relationship (where you only write to each other regularly, but never meet).  

The Question of Generics and Emerging Technology

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, FDA called on Generic firms to be involved and participate in innovation and FDA’s Emerging Technology initiative.  We heard that innovation was not something that should be limited to just Brand Companies.  But, in the field of Generics, where Q1/Q2 and sameness or interchangeability is key,

FDA’s New Weapons to Fight the Opioid Crisis

Yesterday, FDA announced the eligibility of ANDAs submitted for drug products indicated for the emergency treatment of known or suspected opioid overdose, to be granted priority review status (either shorter goal dates, or expedited review without formal reduction of the goal date) under the public health emergency option stated in MAPP 5240.3 (priority criterion number 4).