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Comments Extended on Unapproved Use Guide

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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications Fr...

FDA Withdraws From Device Harmonization Group

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FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the orga...

Info Collection on GLP Requirements

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Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for N...

VariSoft Infusion Sets Recalled

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Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.

Priority Review for Abeona Therapeutics BLA

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FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessi...

Guide on Covid-19 Drugs/Biologics

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Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...

Evive Bios Ryzneuta Approved by FDA

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FDA approves an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as mani...

Entrada Therapeutics DMD Drug Remains on Hold

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Entrada Therapeutics says an ongoing clinical hold against the companys Phase 1 trial of ENTR-601-44 in Duchenne muscular dystroph...

Buprenex Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to...

Covid-19 Treatment, Prevention Products Guidance

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FDA publishes an immediately-in-effect guidance on developing drugs and biologics to prevent or treat some Covid-19.