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 ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
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 ...
Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
(CNN) — 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. In ...
Pharmaceutical Technology on MSN
FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
In May 2025, the FDA approved mepolizumab (Nucala) as a treatment for chronic obstructive pulmonary disease (COPD). Before any drug gets near a pharmacy shelf, it starts with years of basic science ...
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 ...
The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...
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