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CGMP Violations at Janssen Vaccines S. Korea Plant

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FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.

CGMP Deviations in Chengdu Records Review

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FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharma...

FDA Issues Complete Response Letter for Apitegromab

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FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal musc...

Computer Software Assurance Guidance

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FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems i...

2 Items on Genzyme Ireland FDA-483

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FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Water...

Cohance Lifescience FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in ...

Senators Want Overseas Drug Inspection Info

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Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of o...

Olympus Recalls ViziShot 2 FLEX Needles

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Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device c...

FDA Alert on Abiomed Impella Controllers

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FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automat...

FDA Rejects Biogen's High-Dose Spinraza

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FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...