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7 Observations in Natco Pharma FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.

Guide to Characterize Combination Cancer Drugs

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FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.

Fast Track Status for Zenith NUT Cancer Drug

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FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT ca...

Reviewers Question Otsuka PTSD Drug Efficacy

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FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTS...

Partial Hold on Kezars Zetomipzomib Lifted

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FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomip...

Caranx AI Valve Replacement Software Cleared

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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

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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 ...