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FDA Symposium on Trial Data Sharing

[ Price : $8.95]

FDA announces a 9/23 symposium entitled FDA-PDS Symposium X Data Sharing; The Future of Clinical Trial Data SharingThe Art of the...

FDA Inspecting Philips Respironics After Recall

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FDA says it has initiated on-site inspections at Philips Respironics manufacturing facilities to assess compliance with regulatory...

Workshop on Opioid Prescriber Education Under REMS

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Federal Register notice: FDA announces a public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Ri...

Hahn is YourBio Health Interim Chief Medical Officer

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YourBio Health names former FDA commissioner Stephen Hahn as its interim chief medical officer.

New FDA Jardiance Breakthrough Therapy Designation

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FDA grants breakthrough therapy designation to Boehringer Ingelheim and Lillys Jardiance for treating heart failure with preserved...

Draft ICH Gene Therapy Guide

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Federal Register notice: FDA makes available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Th...

Comments Reopened on ICH Q12 Guidance

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Federal Register notice: FDA reopens the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FD...

Info Collection on FDA Communications Testing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Tes...

FDA Rejects Lenzilumab EUA for Hospitalized Covid Patients

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FDA declines to grant emergency use authorization to Humanigens lenzilumab for treating newly-hospitalized Covid-19 patients.

FDA Breakthrough Device Designation for Novocure System

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FDA grants breakthrough device designation to Novocures TTFields system for use with two liver cancer drugs.