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CGMP Violations Cited in Daewoo Warning

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FDA warns South Koreas Daewoo Pharmaceutical Co. about CGMP violations in its production of finished drugs.

FDA Inspection Backlog Can Hurt Canada: Analysis

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A Benefits Pensions Monitor report says FDA drug inspection backlogs can hurt Canada since FDA has been performing 70% of Canadas ...

Ocular Toxicity Concerns with Multiple Myeloma Drug: FDA

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FDA reviewers plan to ask an advisory committee this week about its concerns with ocular toxicity seen in trial data submitted by ...

Issues at San Francisco Research Institute

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FDA warns Dr. Mark Savant and his San Francisco Research Institute about bioresearch monitoring violations in his conduct of a cli...

Biocons Interchangeable Insulin Approved

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FDA approves a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product Kirsty (insulin aspart-xjhz).

8 Observations in Sun Pharmaceutical FDA-483

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FDA releases the form FDA-483 containing eight observations from an inspection at the Sun Pharmaceutical drug manufacturing facili...

FDA Urged to Incentivize Oncology Trials

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Researchers, including CBER director Vinay Prasad, call for incentivized or mandated head-to-head randomized controlled trials of ...

BD Recalls Alaris Pump Due to Infusion Sets

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BD and subsidiary CareFusion issue an Urgent Medical Device Recall (Correction) letter related to performance issues involving the...

CBER Director Overrides Staff to Limit Vaccine

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CBER director Vinay Prasad again overrides career staff to limit a Covid vaccines use, according to a just-posted decisional memo....

Ultragenyx Gets Complete Response on Gene Therapy

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FDA issues Ultragenyx Pharmaceutical a complete response letter on its BLA for UX111 (ABO-102), an investigational gene therapy fo...