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Exceptional Performance of TAP Pilot: Report

[ Price : $8.95]

An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well...

FDA OKs 1st At-Home Stimulator for Depression

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FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.

Medical Device Recall Improvement Act Reintroduced

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Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall ...

Serina Files Response on Parkinsons Drug Clinical Hold

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Serina Therapeutics files a complete response to an FDA clinical hold on SER-252, the companys lead investigational therapy for ad...

FDA Signals Plan to Ease Supplement-Label Disclaimers

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FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion o...

DoJ urges High Court Review of Skinny-Label Dispute

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The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face...

No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

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Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time ...

WLF Warns on New DTC Ad Rules Violating First Amendment

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The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical adv...

FDA OKs 1st Gene Therapy for Wiskott-Aldrich Syndrome

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FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskot...

Revoke All mRNA Covid Vaccine BLAs: CHD Petition

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Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not ...