08
Mar

Age and Sex in ANDA Bioequivalence Studies – Discrimination Could Cause Problems!

On February 24, 2022, the Small Business and Industry Assistance (SBIA) group at the FDA hosted a webinar titled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (you can view the recording here).  The goal was to describe the eight major changes to the August 2021 revision to the guidance Bioequivalence Studies […]

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02
Mar

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  The original draft guidance was issued on July 24, 2013.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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15
Feb

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As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]

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07
Feb

The Unofficial January 2022 OGD Approval Actions Tally

January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days.  Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]

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28
Jan

O-O-O-Ozempic, A Hit with ANDA Submitters

Ozempic (semaglutide) is advertised on TV quite a bit.  The jingle (identified in the title to this post) kind of sticks in your head.  Ozempic is approved “for adults with type 2 diabetes used along with diet and exercise to improve blood sugar and lower A1C.  It also lowers the risk of major cardiovascular (CV) events […]

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