FDA Related News

FDA General

Congressional Committees Set Appropriations Mark-Ups

The Alliance for a Stronger FDA says congressional appropriations committees will be marking up bills for the FY 21 appropriations later this month an...

FDA Workload Likely to Increase Post-Pandemic: Officials

CDER and CBER officials tell a BIO digital conference that they are working to cope with pent-up demand and clinical trial issues in a post-Covid worl...

Human Drugs

FDA Approves Tivicay for Infants, Children with HIV

FDA approves Viivs Tivicay and Tivicay PD for treating pediatric patients for HIV-1.

Federal Register

Comments Extended on Animal Bulk Compounding

Federal Register notice: FDA extends until 10/15 the comment period related to a draft guidance for industry #256 entitled Compounding Animal Drugs fr...

Human Drugs

FDA Approves Mylans Semglee Insulin Glargine

FDA approves Mylans Semglee insulin glargine product as a BLA.

Human Drugs

IntelGenx Working on Rizaport NDA Resubmission

IntelGenx says it learned in a 6/10 meeting with FDA officials about the CMC information that is needed in a resubmission of its Rizaport VersaFilm ND...

Human Drugs

Lannett Sees Clear Path for Insulin Glargine Biosimilar

Lannett says it is on track for a 2022 submission of a BLA for its insulin glargine biosimilar product.

Medical Devices

Covid-19 Diagnostic Test Virtual Town Hall Set

FDA schedules a 6/17 SARS-CoV-2 diagnostic test development and validation virtual town hall.

Human Drugs

Sweeping Changes Coming to OTC Monographs: Attorneys

Mintz Levin attorneys say FDA and industry will need to quickly adapt to OTC monograph reform provisions included in the CARES Act.

Human Drugs

Expand PPI Label Warnings: Petition

The Alliance for Natural Health USA asks FDA to require manufacturers of proton pump inhibitors to include a Warning statement about an increased risk...