FDA Related News

Human Drugs

Hetero Drugs FDA-483

FDA releases an FDA-483 issued following an inspection at Indias Hetero Drugs.

Human Drugs

13 Observations in Akorn Inspection FDA-483

FDA releases an FDA-483 with 13 observations from an inspection at the Akorn sterile drug manufacturing facility.

Human Drugs

Ocular Therapeutix Re-files NDA for Dextenza

Ocular Therapeutix resubmits its NDA for Dextenza (dexamethasone insert) 0.4mg, indicated for treating ocular pain following ophthalmic surgery.

Human Drugs

FDA Approves Terumos Sodium Citrate

FDA approves Terumo BCTs sodium citrate 4% solution USP, indicated for anticoagulating whole blood during automated apheresis procedures.

Human Drugs

Clinical Hold on Mersana Trial After Patient Death

FDA places a clinical hold on a Mersana Therapeutics Phase 1 study of XMT-1522 after the company reported a Grade 5 Serious Adverse Event (patient dea...

Human Drugs

CDERs John Whyte Going to WebMD

CDER professional affairs and stakeholder engagement director John Whyte leaves the agency for WebMD.

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

Novartis Kisqali Approved Through New Review Pilot

FDA approves Novartis Kisqali for a new breast cancer indication using a pilot oncology review program to make the process more efficient and timely.

Federal Register

Draft Guide on Metal Expandable Biliary Stents

Federal Register notice: FDA makes available a draft guidance entitled Metal Expandable Biliary Stents Premarket Notification (510(k)) Submissions....