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Woodcock, Marks Out of Covid Vaccine Review

[ Price : $8.95]

FDA commissioner Stephen Hahn says CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves from all regu...

Web Conference on ICH Good Clinical Practice

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Federal Register notice: FDA announces a 6/4-5 public Web conference to discuss the International Council for Harmonizations good ...

Karyopharm sNDA for Xpovio

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Karyopharm Therapeutics files a supplemental NDA for Xpovio (selinexor), indicated as a new treatment for patients with previously...

Groups Issue Facility Device Rep Reentry Guidance

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AdvaMed joins two national health organizations in suggesting guidelines for allowing medical device company representatives back ...

Covid Real-World Data Agreement Signed

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FDA principal deputy commissioner Amy Abernathy says the agency has an agreement with Aetion to use real-world data to research an...

CGMP Issues at Kumar Organic Products

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FDA warns Indias Kumar Organic Products about CGMP violations in its production of finished pharmaceuticals.

SSS REMS Comments

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Three drug industry stakeholders comment on an FDA draft guidance on developing a shared system risk evaluation and mitigation str...

PhRMA Drug Safety Surveillance Comments

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Pharmaceutical Research and Manufacturers of America praises an FDA draft guidance on postmarket surveillance of drugs, biologics,...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Blaine Labs, Lymol Medical and International Trading Pharm Lab.

Eiger Bio NDA for Zokinvy

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FDA accepts for accelerated review an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Progeria and Progeroid La...