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Drug Interaction Study Guide for Contraceptives

[ Price : $8.95]

FDA issues a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.

Pfizer/BioNTech Submit EUA for Covid-19 Vaccine

[ Price : $8.95]

Pfizer and BioNTech file an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 dat...

Fresenius Kabi Recalls 1 Lot of Dexmedetomidine

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Fresenius Kabi recalls a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vi...

Oncology Drug Cross Labeling Guidance

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FDA issues a draft guidance with recommendations on cross labeling oncology drugs used in combination regimens.

Drug Recalls Up, Device Recalls Down: Report

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The Stericycle recall index for the third quarter of 2020 finds that drug recalls nearly doubled, while medical device recalls fel...

BPCIA and Biosimilar Development Q&A

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FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition an...

FDA Will Review Alvotech BLA for Humira Biosimilar

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FDA has accepted for review an Alvotech USA BLA for a Humira biosimilar.

FDA Adds More ANDA-specific Bioequivalence Guidances

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Federal Register notice: FDA posts 30 additional draft and revised draft product-specific guidances on the design of bioequivalenc...

FDA Debarment Order Against Ex-Insys Manager

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Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a p...

OPDP Core Launch Review Process Updated

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An 11/20 CDER Webinar will explain changes to the Office of Prescription Drug Promotion core launch review process.