24
Apr

Extension of Doxycyline Expiration Dating for National Stockpiles

Back in 2016, FDA indicated that it was planning to issue a guidance document to explain to firms how to extend expiration dating for doxycycline tablets and capsules held in national stockpiles (here) .  Doxycycline is stored in national stockpiles for treatment of post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of […]

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27
Mar
Young man looks at road map near on mountain road, Switzerland

Pediatric Labeling Information Road Map Provides Good Directions

This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive. The guidance goes on to […]

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26
Mar
Young woman with a flat tire

ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  And although […]

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19
Mar

Particulate Material Back in the News

Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product.  One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).  This is reminiscent […]

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11
Mar

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>.  Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products.  This […]

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10
Feb

FDA 10th Annual Report on 505(q) Petitions and Stay of Action Petitions Released

Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday.  This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report […]

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06
Feb
Town Crier Yelling Message

Day Two at AAM Annual Meeting – The Big Guns Come out

Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman. Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics.  This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space.  The panelists described the impact […]

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31
Jan

FDA Draft Guidance – Notice of Marketing Status of NDAs and ANDAs

The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status.  The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently […]

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