FDA Related News

Federal Register

Draft Guide on New Approaches for OTC Drugs

Federal Register notice: FDA has made available a draft guidance entitled Innovative Approaches for Nonprescription Drug Products.

Medical Devices

Stakeholder Comments on 21st Century Cures Software

Stakeholders respond to an FDA request for comment on software excluded from regulation under the 21st Century Cures Act.

Comments on Product Jurisdiction Proposed Rule

Stakeholders offer varied comments on and requests for changes to an FDA proposed rule on product jurisdiction.

Human Drugs

FDA Approves Janssens HIV Drug Symtuza

FDA approves a Janssen NDA for Symtuza (darunavir), a single-tablet regimen for treating human immunodeficiency virus type 1 in treatment-nave and cer...

EHR Data Use Guidance

FDA issues a guidance to help facilitate use of electronic health record data in clinical investigations.

Federal Register

Priority Review Voucher Awarded to Cannabidiol Maker

Federal Register notice: FDA issues a priority review voucher for a rare pediatric disease product application GW Research Ltd.s Epidiolex(cannabidio...

Human Drugs

FDA Biosimilar Product Labeling Guidance

FDA publishes a guidance to help applicants develop draft labeling for proposed biosimilar products.

Human Drugs

FDA Generic Drugs Head Retiring

CDER Office of Generic Drugs (OGD) director Kathleen Uhl announces her intention to retire 2/2019.

Human Drugs

bB BioChem Warned on CGMP Violations

FDA warns bB BioChem Laboratories about CGMP violations in its production of finished pharmaceuticals and about distribution of unapproved new drugs.

Commenters Seek Changes in Product Jurisdiction Rule

Three stakeholders raise concerns and suggest improvements to an FDA proposed rule on product jurisdiction.