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Breakthrough Status for Cognitive Behavioral Therapy

[ Price : $8.95]

FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to...

Guide on Drug/Biologic Covid Studies

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Assessing Covid19-Related Symptoms in Outpatient Adult and ...

McLaren Debarred by FDA for 5 Years

[ Price : $8.95]

Federal Register notice: FDA debars Taylor McLaren for five years from importing or offering for import any drug into the U.S.

BLA Accepted for Treating Lung Cancer

[ Price : $8.95]

FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patie...

Guide on Device Small Business Qualification

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Busine...

Covid Symptoms in Clinical Trials Final Guidance

[ Price : $8.95]

FDA publishes a new final guidance on assessing Covid-19-related symptoms in adults and adolescents who are subjects in clinical t...

FDA Real-World Evidence Guide Stirs Critics

[ Price : $8.95]

Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory ...

More Companies Should Join TAP: Shuren

[ Price : $8.95]

CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.

3 E&C Dems Urge FDA Issue Trial Diversity Guide

[ Price : $8.95]

Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and me...

FDA Posts Medtronic Endotracheal Tube Update

[ Price : $8.95]

FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstru...