Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked ...

FDA chief says Biden administration withheld data on heart risk from Covid vaccines

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

FDA approves topical cattle drug for screwworm, fever tick

The Exzolt Cattle-CA1 aka Fluralaner topical drug has received conditional approval from federal regulators to prevent and ...
JD Supra

FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

In its latest PFDD installment, the FDA offers a detailed roadmap for sponsors seeking to design, adapt, or validate COAs that accurately ...

FDA’s top drug officer set to exit, weeks into new role

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was ...
The Grand Junction Daily Sentinel

Fourth FDA Drug Chief This Year Steps Down, Raising Stability Concerns

Pazdur, who has worked at the FDA for 26 years, told senior leaders on Tuesday that he plans to step down, just weeks after ...

US FDA's newly appointed drugs chief set to retire

The U.S. Food and Drug Administration's newly appointed head of the drug evaluation department, Richard Pazdur, is set to ...
STAT

FDA to lower number of trials required for approval of drugs, other medical products

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...

US FDA removes longtime director of over-the-counter drugs office

The U.S. Food and Drug Administration is moving Theresa Michele, longtime director of the office of non-prescription drugs, ...

Top FDA Drug Regulator Pazdur to Retire Weeks Into New Role

Richard Pazdur, the US Food and Drug Administration’s lead drug regulator, plans to retire from the agency only weeks after ...

NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review.
Marijuana Moment

Doctors Could Legally Administer Schedule I Drugs Like MDMA And Psilocybin To Seriously Ill Patients Under New Bipartisan Bill In Congress

Bipartisan House and Senate lawmakers have introduced a bill in Congress to allow doctors to administer Schedule I drugs such ...