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3 Observations in Atlas Pharmaceuticals FDA-483

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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

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

Woodcock Sets High Priority for OTC Covid Tests

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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

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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

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

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 4/2/2020.

Draft Guide on Dry Eye Drugs

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FDA posts a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsor...

Myovant Sciences Orgovyx OKd for Prostate Cancer

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FDA approves Myovant Sciences Orgovyx (relugolix) for treating adult patients with advanced prostate cancer.

PMA Approved for Above Knee Amputee Implant

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FDA approves an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for a...

CDER Increases Remote Regulatory Assessments

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CDER Office of Compliance director Donald Ashley tells a Food and Drug Law Institute conference that FDA is continuing to explore ...