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AdvaMed Recommendations for Patient Preference

[ Price : $8.95]

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and al...

Teleflex Pacing Guidewire Cleared

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FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use ...

ICH Guide on Good Clinical Practice

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Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.

Braun EUA Revoked on Propofol-Lipuro

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Federal Register notice: FDA revokes an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injecta...

CBER Post-Covid Transition Information

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CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emer...

Legend Bio sBLA to Expand Carvyktis Use

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Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatm...

Eisai/Biogen Alzheimers Drug Effective: FDA

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FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits an...

Bioresearch Monitoring Issues in Mazhar Trials

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FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical trials.

PMI Major Change in Drug Labeling: Attorneys

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Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant c...

FDA OKs Mercks Prevymis for Kidney Transplants

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FDA approves Mercks Prevymis (letermovir) for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients.