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FDA PD-1 Concerns Spread to AstraZeneca/Celgene Trials

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FDA concerns about PD-1/PD-L1 inhibitors spread to clinical trials for multiple myeloma, lymphoma and leukemia conducted by AstraZ...

FDA Wants Input on Regulation Review: Post

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FDA deputy commissioner Anna Abram says the agency is soliciting public input as it reviews all of its regulations looking for way...

CDER Researchers Looking at Protein Chemical Changes

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CDERs V. Ashutosh Rao describes the work Office of Biotechnology Products laboratory researchers are doing to improve the quality,...

FDA Issues for Orphan Drug Approvals

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FDAers discuss issues facing the agency in trying to continue its momentum in approving orphan drug designations.

EpiPen Contractor Warned on Drug CGMP, QS Violations

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FDAs Kansas City District Office warns Mylan EpiPen product supplier Meridian Medical Technologies about CGMP and QS violations in...

Workshop on CDER Rare Disease Drug Development

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Federal Register notice: FDA announces a 10/30 public workshop entitled CDER Rare Diseases Public Workshop: Strategies, Tools, and...

FDA Revamping its Industry Advice for New Technologies: Gottlieb

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FDA commissioner Scott Gottlieb says the agency plans to revamp its early pre-clinical involvement with medical product developers...

FDA Clears eNeura Expanded Use for Migraine Device

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FDA clears an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache.

Separate Kayexalate from Other Oral Meds: FDA

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FDA recommends patients not take Kayexalate and other oral medicines at the same time to prevent reducing the effectiveness of the...

PharMedium Recalls Compounded Oxytocin

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PharMEDium Services recalls all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin com...