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FDA OKs Somryst Prescription Digital Therapeutic

[ Price : $8.95]

FDA authorizes Pears Somryst prescription-only digital therapeutic intended to treat chronic insomnia in adults age 22 and older.

FDA Says Digital Health Policies Help Covid-19 Solutions

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FDA says it does not regulate as medical devices many digital health solutions used by public health officials and the public to m...

Comments on AI Used in Radiological Imaging

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FDA extends the comment period on a 2/25-26 public workshop on artificial intelligence in radiological imaging.

FDA Ends Clinical Data Summary Pilot

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CDER ends its clinical data summary pilot program.

Stimulus Bill Includes New OTC Drug User Fees

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The coronavirus-related economic stimulus legislation includes language to allow FDA to create a new user fee program for over-the...

Moderna Covid Vaccine SEC Filing

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Moderna tells the SEC its clinical trial of a potential Covid-19 vaccine is proceeding according to protocol and could be offered ...

Alston Bird FDA Domestic Inspection Analysis

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Alston Bird attorneys say the drug industry must be prepared for FDA to creatively use existing authorities instead of physical in...

Bristol Myers Pauses New Clinical Trials

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Bristol Myers Squibb says it will not initiate any new clinical trials globally before 4/13 due to coronavirus concerns.

April Cosmetics Regulation Meeting Canceled

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Federal Register notice: FDA cancels a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation Preparation...

FDA to Fund Real-World Data Projects

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FDA says it will fund projects to help it better understand using real-world data to generate real-world evidence.