FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency post...

latest-news-card-1
Human Drugs

WLF Warns on New DTC Ad Rules Violating First Amendment

The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a col...

latest-news-card-1
Human Drugs

FDA OKs 1st Gene Therapy for Wiskott-Aldrich Syndrome

FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome.

latest-news-card-1
Biologics

Revoke All mRNA Covid Vaccine BLAs: CHD Petition

Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA requ...

latest-news-card-1
Human Drugs

FDA Qualifies 1st AI Drug Development Tool

FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated steatohepatitis clinical...

latest-news-card-1
Human Drugs

FDA Issues Promotional Guide for Biosimilars/Reference Biologics

FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Pro...

Human Drugs

FDA Says Looking at Safety of RSV Infant Therapies

FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.

latest-news-card-1
Medical Devices

Envoy Medical QS Violations

FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hearing system.

Biologics

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric deaths allegedly tied...

FDA General

Experts Call for Overhaul of FDA Revolving Door Rules

Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles,...