FDA Related News

Medical Devices

Follow At-Home Covid-19 Test Instructions: FDA

FDA alerts people to potential injury if at-home Covid-19 tests are not used according to the approved manufacturer instructions.

Medical Devices

EUA for Indicaid Covid-19 Rapid Antigen Test

FDA grants emergency use authorization for an Indicaid rapid at-home over-the-counter Covid-19 antigen test.

Human Drugs

FDA Approves Marinus Ztalmy for Rare Epilepsy

FDA approves Marinus Ztalmy to treat a rare form of epilepsy in patients age 2 and older.

Human Drugs

Improve Mfg. Deficiencies to Boost ANDA Approval: FDA

A CDER chart says that avoiding the most common manufacturing deficiencies can improve the quality of ANDA applications and thus the number of first-c...

5 Issues Facing Califf

Barrons identifies five issues facing FDA in the next few months that will shed light on how commissioner Robert Califf approaches his job and the age...

FDA Planning Foreign Inspection Improvement Pilots

FDA plans several pilot programs to evaluate ways to improve foreign inspections.

Human Drugs

FDA Mostly Denies Novartis Zolgensma Petition

FDA substantively denies a Novartis due diligence petition because the company failed to demonstrate that Regenxbio did not act with due diligence dur...

Human Drugs

Fast Track for 7 Hills Pharma Cancer Drug

FDA grants fast track designation for 7 Hills Pharmas lead clinical-stage immunosuppressant to treat some malignant melanomas.

Human Drugs

CDER Meeting on Naloxone Availability

FDA and the Reagan-Udall Foundation announce a 3/29 virtual public workshop to discuss critical questions around access to naloxone and its use to rev...

Medical Devices

Too Few High-Risk CV Device Post-Approval Studies

Despite a statutory mandate, researchers say FDA has not increased post-approval trials with clinical endpoints for high-risk cardiovascular medical d...