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Hahn Admits to White House Covid Pressure

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Outgoing FDA commissioner Stephen Hahn says he was under significant White House pressure on Covid vaccines and treatments.

Covid Alcohol Testing Policy

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FDA issues an immediately effective guidance on methanol testing in drug products during the Covid-19 public health emergency.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 1/15/2021.

Meeting on Vitiligo Patient Perspetives

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Federal Register notice: FDA reschedules a public meeting for 2/12 on Patient- Focused Drug Development for Vitiligo.

Meeting on eSubmissions and Data Standards

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Federal Register notice: FDA announces a 4/7 virtual public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Su...

FDA Withdrawing 27 No-longer-marketed ANDAs

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Federal Register notice: FDA withdraws approval of 27 ANDAs from multiple applicants after they notified the agency that the drug ...

Guidance on Bioequivalence Studies During Covid Emergency

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FDA releases a new guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications Durin...

Survey of Drug Product Manufacturing Quality

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Federal Register notice: FDA sends to OMB an information collection entitled Survey of Drug Product Manufacturing, Processing, and...

FDA-483 Posted on BMS Liso-cel Pre-approval Inspection

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An FDA inspection at Lonzas Viral Vector contract-manufacturing facility leads to a four-item FDA-483 and resumption of the agency...

Safety Alert on Preparing Vinca Alkaloids

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FDA alerts health care professionals about labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents...