Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
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 ...
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.
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
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 ...
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: ...
The Food and Drug Administration is seeking comments on how to handle approval of animal food ingredients following last week’s announcement it will not be renewing a memorandum of understanding with ...
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