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Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Heritage Pharmaceuticals and Life Support Development.

ADE Reporting Violations at Heritage Pharmaceuticals

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FDAs New Jersey District Office warns Heritage Pharmaceuticals about violations of Postmarketing Adverse Drug Event Reporting requ...

Misinformation: PhRMA Blasts BMJ Trial Study

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PhRMA says a study on compliance with clinical trial reporting requirements published online by BMJ Open spreads misinformation an...

Alexion Pharma Receives Voucher for Strensiq

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Federal Register Notice: FDA issues a priority review voucher to Alexion Pharmaceuticals for Strensiq, a therapy for infantile- an...

Guidance on Labeling for Drugs Containing Acetaminophen

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Federal Register Notice: FDA releases a guidance: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug...

FDA Proposes Bacillus Species Detectors into Class 2

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Federal Register Proposed rule: FDA re-proposes to classify in vitro diagnostic devices for Bacillus species (spp.) detection into...

AMA Votes to Support DTC Advertising Ban

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The American Medical Association votes to support a ban on pharmaceutical direct-to-consumer (DTC) advertising.

FDA Guidance on Biosimilar Meeting Requests

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FDA posts a final guidance on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.

FDA Asks for More Data on Clovis Lung Cancer Drug

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FDA requests additional efficacy clinical data as part of its review of an NDA for rociletinib (500mg and 625mg BID), indicated fo...

FDA Cancels Panel Meeting on Organ Perfusion System

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Federal Register Notice: FDA cancels the 11/18 Gastroenterology and Urology Devices Panel meeting and postpones the 11/19 session.