If You Have a Flair for the Plair, Your Final Guidance Has Just issued!

Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval.  The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]

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Recommended Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is Non-Binding

As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]

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FDA Finalizes Guidance on Annual Reportable CMC Changes for Specified Biologic Products

In today’s Federal Register (here), the FDA announced the availability of a final guidance for chemistry manufacturing and control changes (CMC) that may be reported in an annual report (AR).  CMC changes that may be submitted in an annual report are considered minor changes.  The FDA says, “This final guidance updates the draft guidance of […]

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AAM’s GRx-Biosims Day 2 – Afternoon Sessions 

The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2) and the other on Generic Drug Case Law. The combination product similarity session described the various permutations of the sameness […]

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FY 2022 Fees for Using Priority Review Vouchers Announced 

Today’s prepublication of the Federal Register (FR) contains the fees to be assessed for three priority review vouchers, namely the material threat medical countermeasure (MCM) priority review voucher; the rare pediatric disease priority review voucher, and the tropical disease priority review voucher.  These fees were announced in three separate FR notices (here, here, and here).  These vouchers are awarded to sponsors that submit and […]

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