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Human Drugs

GW Pharma sNDA for Cannabidiol Product

GW Pharmaceuticals submits a supplemental NDA for Epidiolex (cannabidiol) oral solution for an expanded use to include seizures associated with Tubero...

Human Drugs

DC Judge Rules for FDA in Vanda Clinical Hold

A DC federal judge sides with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency imposed prohibiting Vand...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 1/31/2020.

Human Drugs

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Guide on Retroviral Vector-Based Gene Therapies

Federal Register notice: FDA makes available a final guidance on testing retroviral vector-based human gene therapy products.

Federal Register

Guide on Gene Therapy Observational Studies

Federal Register notice: FDA makes available a final guidance entitled Long Term Follow-Up After Administration of Human Gene Therapy Products.

FDA General

FDA Warning on Nicotine Toothpicks

FDA issues a Warning Letter to Smart Toothpicks (Tempe, AZ) after the agency determined that its dissolvable tobacco products, Peppermint Ice Nicotine...

Federal Register

Guide on Creutzfeldt-Jakob Disease Risk Reductions

Federal Register notice: FDA makes available a draft guidance on recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob Dise...

Medical Devices

Olympus Enhanced Reprocessing Duodenoscope Cleared

FDA clears an Olympus 510(k) for the TJF-Q190V duodenoscope with a sterile, disposable distal endcap for enhanced reprocessing.

FDA General

Hahns 1st Address Targets Data Modernization as Priority

In his first address to FDA employees, FDA commissioner Stephen Hahn says unleashing the power of data will be a key objective while he is at the agen...