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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Family Pharmacy and Sound Healing Arts, PC, dba Grounds for Tea.

FDA Grants Progesterone Gel Guidance Request

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FDA grants and denies portions of a Watson petition on bioequivalence guidance and studies for progesterone gel.

CGMP, Other Violations at American Family Pharmacy

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FDAs Detroit District Office warns American Family Pharmacy about CGMP and misbranding violations.

FDA Breakthrough Status for Mercks Keytruda

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FDA grants Merck a breakthrough therapy designation for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with ...

Vertex Pharma Receives Subpoena Over GLPs

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Vertex Pharmaceuticals says it received a subpoena from the U.S. Department of Justice in the third quarter related to its Good La...

OIG Aims to Examine Post-marketing Requirements

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HHS Office of Inspector General plans to examine how FDA requires NDA holders to conduct postmarketing studies and the agencys ove...

FDA Grants Expedited Access Designation for MyoRegulator

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FDA grants PathMaker Neurosystems an Expedited Access Pathway designation for its MyoRegulator PM-2200 system for use in treating ...

Guidance on Dispenser Product Tracing Requirements

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Federal Register Notice: FDA issues a revised guidance: DSCSA Implementation: Product Tracing Requirements for Dispensers Complia...

Guidance on Progesterone Gel BE Studies

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Federal Register Notice: FDA releases a document for industry: Draft Guidance on Progesterone to provide recommendations on bioequ...

Guidance on Electromagnetic Compatibility of Devices

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Federal Register Notice: FDA releases a draft guidance: Information to Support a Claim of Electromagnetic Compatibility (EMC) of E...