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2 Meetings on Adverse Event Reporting

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Federal Register notice: FDA announces two public meetings on electronic submission of adverse event reports using International C...

GE Recalls Unstable Nuclear Medicine Devices

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GE HealthCare recalls its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent ...

Drug R&D Cant Justify High Prices: Study

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UK-based researchers say their analysis of drug company financial records doesnt support company claims that high drug prices are ...

Further FDA Opioid Crisis Strategies: Califf

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FDA commissioner Robert Califf outlines ways the agency is taking additional steps as part of its response to the nations opioid c...

30 New Product-Specific Guidances Out

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FDA releases a batch of 30 new and revised product-specific guidances to aid in the development of generic drugs.

Pfizer Says Talzenna Prostate Cancer Study Positive

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Pfizer says FDA has granted priority review for its sNDA for Talzenna and Xtandi which showed positive results in a Phase 3 study ...

FDA Approves BioVex BLA Supplement

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FDA approves a BioVex BLA supplement to update the adverse drug reactions for its talimogene laherparepvec melanoma treatment.

Merit Medical Breakthrough Status for Scout Device

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FDA grants Merit Medical Systems a breakthrough device designation for its Scout MD Surgical Guidance System.

GAO Identifies FDA Gaps in IRB Oversight

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The Government Accountability Office calls on FDA and the HHS Office of Human Research Protections to take steps to improve their ...

FDA Pushed Into Accelerated Approval Pricing Model

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HHS directs FDA to work with CMS Innovation Center to test a proposed model that would adjust Medicare payments for accelerated ap...