FDA issues a draft guidance for sponsors developing drugs to treat uncomplicated urinary tract infections.
Harvard Medical School researchers Michael Sinha and Arnold Kesselheim say advocates of reduced government oversight of off-label drug promotion are t...
FDA clears a Prisyna 510(k) for its Moisyn product designed to treat xerostomia (dry mouth).
Federal Register notice: FDA establishes a public docket to assist with its development of a policy/guidance document on assessing drug-drug interacti...
CDER director Janet Woodcock says the practical effect of granting a drug candidate breakthrough therapy designation is that the drug and its sponsor ...
Federal Register notice: FDA makes available a draft guidance entitled Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the...
FDA says an outbreak of B. cepacia infection has been linked to Medline Remedy Essentials No-Rinse Cleansing Foam.
FDA commissioner Scott Gottlieb says the agency is listening to patients on how loperamide restrictions may affect them.