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FDA Nixes Post-marketing Requirements on Impella Pumps

[ Price : $8.95]

FDA closes its post-approval study requirements for Abiomed PMAs for its Impella heart pumps after reviewing favorable performance...

PhRMA Raises QMM, KASA Issues

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PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs ...

FDA Launches Advancing RWE Program

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FDA launches its Advancing Real-World Evidence Program intended to improve the quality and acceptability of real-world evidence ap...

FDA Extends Novel Trial Design Meeting Program

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Federal Register notice: FDA announces that it is continuing a meeting program to advance the use of complex adaptive, Bayesian, a...

PTC Says Huntingdons Trial Paused in the U.S.

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PTC Therapeutics says enrollment in its Phase 2 Huntingdons disease trial has been paused in the U.S. due to an FDA request for ad...

Philips Mask Recall is Class 1

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FDA says the 8/2 Philips Respironics recall of certain BiPAP and CPAP masks is Class 1.

UDI Enforcement Policy, Alternatives FAQs

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FDA posts frequently asked questions on UDI enforcement policy that changes with devices labeled on or after 9/24/23.

FDA Panel Shoots Down Makenas Continued Availability

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An FDA advisory committee votes 14 to 1 to recommend the market withdrawal of Covis Makena (hydroxyprogesterone caproate injection...

OMB Approves 5 Information Collections

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FDA announces that OMB has approved five information collection notices.

Advisory Panel Rescheduled for Covid Therapy

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Federal Register notice: FDA amends a 9/8 notice that announced a 10/6 Pulmonary-Allergy Drugs Advisory Committee meeting to discu...