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NDA Guidance on Pancreatic Enzymes is Withdrawn

While it is no surprise, the prepublication notice in the Federal Register today (here) announces the withdrawal of the FDA guidance Exocrine Pancreatic Insufficiency Drug Products–Submitting New Drug Applications.  The announcement comes just 19 days prior to the date when these products can no longer be submitted as an NDA.  Remember, FDA had noted in […]

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Promotional Labeling is the Target of New Q&A Document on Biosimilars and Reference Products

Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here).  The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]

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