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The FDA’s case for implementing its drug-tracking rule just became more difficult as a federal court has seemingly undercut one of the government’s central arguments against a stay on the rule, an industry official says.
The FDA introduced changes to its regulations to make experimental drugs more available to seriously ill patients who have exhausted other treatment options.
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, and one of the agency’s more public faces, is going back to the private sector in January, the agency announced.
The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late last week.
The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late yesterday.