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Supreme Court Asked to Look at Bioequivalence Safe Harbor

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Two Fenwick & West attorneys say the Supreme Court will decide whether to hear an appeal of a Federal Circuit Appeals Court decisi...

CVM Approves Injectable Analgesic for Dogs

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FDAs Center for Veterinary Medicine approves Arata Therapeutics Nocita (bupivacaine liposome injectable suspension) for post-opera...

CGMP Violations in Noven Inspection

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FDAs Florida District Office warns Noven Pharmaceuticals about CGMP violations in its manufacturing of finished pharmaceuticals.

Import Alert for All Laxachem Organics Products

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FDA says it has placed an import alert on all Laxachem Organics products from India because the company refused to allow an agency...

Compliance Remediation Projects Needed: Consultants

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The FDA Group offers guidance to manufacturers on regulatory compliance remediation.

More Info Sought on Chewable Tablet Guidance

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Drug companies ask FDA for additional information on a draft guidance on quality attributes of chewable tablets.

Woodcock Backs Patient Input, Expanded Sentinel in Next PDUFA

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CDER director Janet Woodcock supports enhancing the science of patient input into regulatory decision making and Sentinel drug saf...

CDER Draft Guide on Pharmaceutical Co-Crystals

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CDER posts a draft guidance on Regulatory Classification of Pharmaceutical Co-Crystals that provides sponsors with information on ...

FDA Clears Centric Tarsa-Link Bunion Device

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FDA clears a Centric Medical 510(k) for the Tarsa-Link Bunion Correction System.

Dissemination of Patient-Specific Information Guidance

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Companies raise questions about an FDA draft guidance on medical device manufacturer dissemination of patient-specific information...