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510(k) Certification Information Collection

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Federal Register notice: FDA revises an information collection entitled Premarket Notification 21 CFR Part 807, Subpart E.

510(k) Guidances for 2 Ultrasound-type Devices Published

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FDA publishes two 510(k) guidances on ultrasound and related types of devices.

Intarcia Agrees to Advisory Committee to Resolve Review Dispute

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Intarcia Therapeutics accepts an FDA proposal to allow an advisory committee to review and address a 2021 CDER decision not to app...

Lagevrio Misses Endpoint in Covid-19 Study

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Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not meet the primary endpoint a statistically significant ris...

Regulatory Agenda Eyes DTC Ads and Med Guides

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HHS publishes its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, including a fin...

Pfizer Drops Many U.S. Lyme Trial Participants

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Pfizer drops about half of the U.S. participants in its VALOR Lyme vaccine Phase 3 trial due to trial site good clinical practice ...

Priority Review for Merck Prevymis sNDA

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FDA grants priority review for a Merck sNDA to extend the use of its Prevymis to CMV prophylaxis in kidney transplant patients.

FDA to Review Iveric NDA for Avacincaptad Pegol

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FDA accepts an Iveric Bio NDA for avacincaptad pegol for priority review with a Breakthrough Therapy designation to treat geograph...

Comments Sought on WHO Drug Scheduling

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Federal Register notice: FDA provides an opportunity to submit written comments on recommendations by the World Health Organizatio...

Eisai Expects FDA to Approve Alzheimers Drug Soon

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Eisai CEO Ivan Cheung says he expects full FDA approval for the early Alzheimers drug Leqembi by this summer if the agency gives t...