October 3, 2022

PDUFA VI: Fiscal Years 2018 – 2022

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription […]
October 3, 2022

Split Real Time Application Review (STAR)

Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter[1], FDA is creating the Split Real Time Application Review (STAR) pilot program.   Overview FDA […]
October 3, 2022

April – June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Afinitor (everolimus) Afinitor Disperz (everolimus) Rapamune (sirolimus) Zortress (everolimus) Drug interaction FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Jemperli (dostarlimab-gxly) Keytruda […]
October 1, 2022

PDUFA VI Commitment: Assessment in Support of Sentinel System

FDA is committed to enhancing the U.S. drug safety system and envisions the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA […]
September 30, 2022

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally […]
September 30, 2022

FDA Continues Important Work on Substance Use and Overdose Prevention Efforts

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and […]
September 30, 2022

Drug Shortages

Coronavirus Disease (COVID-19):  The FDA continues to take steps to monitor the supply chain.  The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and […]
September 30, 2022

FDA Drug Competition Action Plan

Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and […]
September 30, 2022

BEST Resource Taxonomy

Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on qualification of drug development […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0