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Draft Guide on Pediatric Extrapolation

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Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.

Drug Interaction Studies Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.

Info Collection on User Fee Review Transparency

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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

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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

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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

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

FDA Removes N95 Respirators from Shortages List

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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

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

Integra LifeSciences Removes CereLink Intracranial Monitors

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Integra LifeSciences begins a global product removal of all CereLink intracranial pressure monitors after customer reports were re...

Incytes Pemazyre OKd for Rare Blood Cancer

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FDA approves an Incyte supplemental NDA for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor for tr...