March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...
The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...
The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...
The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
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Bureaucracy's rot runs amok at FDA
Bureaucracy's Rot Runs Amok at FDA ...
The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
The FDA is planning to only ask for one pivotal clinical trial instead of the long standard of two trials for drug approval. The present FDA commissioner believes it carries the same statistical power ...
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
Vanda Pharmaceuticals’ seven-year ambition to score a coveted label expansion for sleep drug Hetlioz has taken an unusual turn, with the FDA acquiescing to a formal hearing on the matter. | The ...
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...
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