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 ...

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 ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

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 ...

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...

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

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...