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FDA Alert on Oxygenator Recall

[ Price : $8.95]

FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall ...

Panel Backs Full Approval of Alzheimers Drug

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An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens ...

SurGenTec Sacroiliac Joint Fusion Device Cleared

[ Price : $8.95]

FDA clears a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System.

FDA Sees Need to Better Address Drug Shortages

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FDA says that while drug shortages have declined since 2011, there still are needs to be addressed to help the agency prevent or m...

Oral Contraceptive Drug Interaction Guidance

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FDA publishes a guidance to help IND and NDA sponsors evaluate the drug-drug interaction effects of their investigational drugs on...

Keytruda sBLA for Biliary Tract Cancer

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FDA accepts for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patien...

Avita Skin Defect Device Get Expanded Use

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FDA approves an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects.

Buspar Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Bristol Myers Squibbs Buspar (buspirone HCl) was not withdrawn due to safety or effec...

Info Collection Extension of Drug Import Plans

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Federal Register notice: FDA seeks comments on an information collection extension entitled Importation of Prescription Drugs 21 ...

Antimicrobial Drugs Panel Renewed

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Federal Register notice: FDA renews its Antimicrobial Drugs Advisory Committee for an additional two years.