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Contract Testing Lab Gets Warning Letter

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FDA sends contract testing laboratory Sure-Biochem Laboratories a Warning Letter after a 10/2022 inspection cited significant GMP ...

New FDA MOU for Distributed Manufacturing

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FDA and the Veterans Health Administration announce a new memorandum of understanding to advance distributed manufacturing and dig...

Figures in Tellus Clinical Trial Fraud Case Acquitted

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A Miami federal jury 5/18 acquits Tellus Clinical Research CEO Fidalgis Font and clinical study coordinator Julio Lopez in their a...

Safety Alert on Pediatric Cough Drops

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FDA issues a safety alert on Novis-branded over-the-counter G-Supress DX Pediatric Drops because they may contain the incorrect pr...

Regulatory Review Period Corrected for Enspryng

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Federal Register notice: FDA corrects a 7/13/2022 notice that announced the regulatory review period determination for Genentechs ...

Ex-FDAer Schiller on Accelerated Approval Guide

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Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should addr...

Melanoma Imaging Device Get Breakthrough Status

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FDA grants Orlucent a breakthrough device designation for the companys Orlucent Skin Fluorescence Imaging System.

Lawyers Motion to Remain Anonymous Granted

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In an unprecedented decision, the DC District Court temporarily grants an attorneys motion to keep his identity secret in connecti...

FDA OKs New Opioid Use Disorder Option

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FDA approves a Braeburn Inc. NDA for Brixadi (buprenorphine) extended-release injection (subcutaneous) for treating moderate to se...

Abbott Touts Data on Dual Chamber Pacemaker

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Abbott reports new data from an IDE study of its AVEIR dual-chamber i2i leadless pacemaker, described as the worlds first.