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FDA Extends Molgramostim BLA Review for 3 Months

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FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.

FDAs No. 2 Brenner May Move to CDC Senior Role

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The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.

FDA Updates Compliance Program for Biologic Drug Manufacturers

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FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug ...

2 CDER Postmarketing MAPPS Out

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CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and...

FDA Panel Meeting to Mull Adding Peptides to Compounding List

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FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs f...

CGMP Violations Found at Medical Products Laboratories

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FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.

Multiple Issues in Purolea Cosmetics Lab Inspection

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FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contrac...

Dont Underestimate Device Quality System Inspection Changes: Column

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Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town ...

Guidance on Sequencing Standards for Genome Editing Therapies

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FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editin...

Exelixis Wants 505(b)(2) Cabometyx Restrictions

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Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing...