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Alert on Respironics Airway Pressure Devices

[ Price : $8.95]

FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a...

Guide on Evaluation of QT/QTc Interval Prolongation

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled E14 and S7B Clinical and Nonclinical Evaluatio...

Draft Guide on Pediatric Extrapolation

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.

Drug Interaction Studies Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.

Info Collection on User Fee Review Transparency

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Review Transparency and Communication for Ne...

FDA Issues EUA for Covid Test, Revokes 4 Others

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of one, and revocation of four Emergency Use Authorizations issued to STS Lab ...

Moderna Files Patent Suit Against Pfizer/BioNTech

[ Price : $8.95]

Moderna files a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 v...

2 ICH Guidances on Drug Analytical Procedures

[ Price : $8.95]

FDA makes available two International Council for Harmonization draft guidances on drug analytical procedures.

FDA Removes N95 Respirators from Shortages List

[ Price : $8.95]

FDA removes N95 respirators from its medical device shortage list, which it says signals that demand or projected demand for this ...

ICH Guide on Evaluating QT/QTc Interval Prolongation

[ Price : $8.95]

FDA releases a final guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrh...