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FDA General

Covid-19 to Spur Wide Vaccines Growth: Alliance

Alliance for a Stronger FDA says the vaccines development industry is likely to see a renaissance under pressure from the Covid-19 pandemic.

Human Drugs

FDA Green Lights Remdesivir for Covid-19 Emergency Use

FDA grants Gilead Sciences an emergency use authorization for its antiviral drug remdesivir for treating suspected or laboratory-confirmed Covid-19 in...

Human Drugs

Comments on FDA Data Strategy

Three stakeholders comment for the FDA docket on updating the agency data strategy.

Human Drugs

New Safety Signal MAPP

CDER issues a MAPP on its approach to newly identified safety signals in marketed drugs.

Federal Register

Info Collection on Combo Product Constituent Parts

Federal Register notice: FDA seeks comments on an information collection extension entitled Information Sharing Among Constituent Part Applicants 21 ...

Federal Register

Guide on Accredited Third-Party Certification Program

Federal Register notice: FDA makes available a final guidance entitled Temporary Policy Regarding Accredited Third-Party Certification Program Onsite ...

Federal Register

Ophthalmic Devices Panel Meeting Postponed

Federal Register notice: FDA postpones a 6/9-planned Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting that was going to revi...

Human Drugs

Court Orders Halt to Covid Silver Product Sales

The Utah federal court orders two companies and their owner to stop selling silver products as a preventive or treatment for Covid-19.

Human Drugs

FDA Says Infuze MD Markets Unapproved Drugs

FDA says Infuze MD is selling an unapproved cellular product.

Human Drugs

FDA Approves Singulair Boxed Warning

FDA approves a Boxed Warning for Singulair to strengthen awareness of potential mental health side effects.