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Teleflex Pacing Guidewire Cleared

[ Price : $8.95]

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

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.

Braun EUA Revoked on Propofol-Lipuro

[ Price : $8.95]

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

[ Price : $8.95]

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

Adderall Shortage Process Muddy, Obscure: Wyden

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Sen. Ron Wyden calls on FDA and the DEA to issue a joint statement on the current Adderall shortage and to answer questions about ...