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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.

Rutgers-led Research to Focus on Continuous Manufacturing

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FDA awards $4.9 million in grant funding to the Rutgers University School of Engineering to support the introduction of continuous...

FDA Report Examines Laboratory-developed Test Accuracy

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A new FDA report examines how increased regulatory oversight is needed to ensure laboratory-developed tests (LDTs) to limit inaccu...

NY Times Editorial Seeks Answers to Califfs Industry Ties

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A New York Times editorial says a Senate Committee hearing 11/17 needs to grill FDA commissioner nominee Robert Califf on whether ...

CDRH Seeks Participants for Training Program

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Federal Register Notice: CDRH is seeking participants for its 2015 Experiential Learning Program General Training Program.