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GSK Scraps Monoclonal Antibody Development for RA

[ Price : $8.95]

GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-...

Info Collection on 3rd Party Review Program

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Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.

FY 2023 GDUFA Research Priorities

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FDA posts eight generic drug research priority initiatives for FY 2023.

Baxter WatchCare Urgent Correction

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FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause ...

Developing, Responding to Device Deficiencies Guidance

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FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing ...

MDIC Cybersecurity Maturity Benchmark Report

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The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity...

Califf Hoping for LDT Legislation

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FDA commissioner Robert Califf says he hopes Congress will include regulation of laboratory-developed tests and several other issu...

FDA Postpones Meeting on OTC Birth Control Pill

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FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (nor...

Priority Review for Seres BLA for c.diff Therapy

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FDA accepts for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventin...

Workshop on PET Imaging in Alzheimers Patients

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Federal Register notice: FDA announces an 11/17 public workshop entitled Quantitative Brain Amyloid PET Imaging in Patients with A...