The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Anaphylm's FDA approval process is a major catalyst, with a PDUFA date set for January 31, 2026, and potential AdCom or partnership news ahead. Anaphylm offers a needle-free, orally delivered ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...