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FDA Patient Cybersecurity Best Practices Video

[ Price : $8.95]

FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.

3 Observations in Atlas Pharmaceuticals FDA-483

[ Price : $8.95]

FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, A...

Flume Balloon Urinary Catheter Cleared

[ Price : $8.95]

FDA clears a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter.

Woodcock Sets High Priority for OTC Covid Tests

[ Price : $8.95]

FDA acting commissioner Janet Woodcock testifies before Congress about an agency priority to increase the availability of over-the...

FDA Updates Hill on Covid Therapies, Inspections

[ Price : $8.95]

FDA testimony at a Senate hearing on Covid-19 discusses the unprecedented number of new product submissions to fight the disease a...

Diabetes Treatment Goal Can Cause Problems: Reuters

[ Price : $8.95]

A Reuters series documents the role diabetes drug marketing techniques played in a significant increase in cases of hypoglycemia a...

Software Function Premarket Submission Guidance

[ Price : $8.95]

FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.

FDA Evaluating Compounding MOU Court Action

[ Price : $8.95]

FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the int...

Adakveo Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Adakveo (crizanliz...

Dengvaxia Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Dengvaxia (dengue t...