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Baxter WatchCare Urgent Correction

[ Price : $8.95]

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

[ Price : $8.95]

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

MDIC Cybersecurity Maturity Benchmark Report

[ Price : $8.95]

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

Califf Hoping for LDT Legislation

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

ICH Presentation on Selective Safety Data Collection

[ Price : $8.95]

The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to...

Positive Results in AZ Breast Cancer Trials

[ Price : $8.95]

AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.

Rare Disease Endpoint Pilot Program

[ Price : $8.95]

Federal Register notice: FDA launches a Rare Disease Endpoint Advancement Pilot Meeting Program.