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J&J Subsidiary Pays $10 Million on Drug/Device Promo Violations

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Johnson & Johnson subsidiary Medical Device Business Services agrees to pay $10 million to settle allegations under the False Clai...

Covid-19 Device EUA Listing Updated

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Federal Register notice: FDA updates its ongoing listing of issued and reissued Emergency Use Authorizations for medical devices r...

Drug Interaction Study Guide for Contraceptives

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FDA issues a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.

Pfizer/BioNTech Submit EUA for Covid-19 Vaccine

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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FDA issues a draft guidance with recommendations on cross labeling oncology drugs used in combination regimens.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FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition an...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...