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Caranx AI Valve Replacement Software Cleared

[ Price : $8.95]

FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...

Sandoz Recalls Mislabeled Cefazolin for Injection

[ Price : $8.95]

Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...

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...