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More FDA Regulation of Health Apps Needed: Study

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Researchers argue for expanded FDA regulation of health apps to prevent harm to consumers.

FDA Fast Track for Moderna mRNA Drug

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FDA grants Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia.

FDA Should Regulate Genetic Tests: Disability Council

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The National Council on Disability says FDA and other federal agencies should have active oversight over prenatal genetic testing.

Provention Bio Crohns Trial Misses Endpoint

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Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohns disease drug PRV-6527 showed that the therapy ...

3 Observations in East Marietta FDA-483

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FDA releases the FDA-483 with three observations from an inspection at East Marietta Drug Company.

FDA Denies Most of 2 Dopamine Agonist Petitions

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FDA denies most requests in Public Citizen and BioMedEcon petitions seeking stronger labeling and other actions for dopamine agoni...

Stand Down on LDT Oversight Until Congress Acts: Attorney

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Attorney Jeffrey Shapiro calls on FDA to stop all enforcement oversight of laboratory-developed tests until Congress specifically ...

FDA and FTC Warn CBD Marketer

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FDA and FTC send a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containin...

Vaccine Study Dataset Submission Guide

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FDA makes available a final guidance entitled Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review...

Final Guide Drug Manufacturing Establishment ID

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FDA posts a final guidance entitled Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Ques...