FDA launches a Rare Disease Endpoint Advancement pilot program as called for in the PDUFA 7 reauthorization.
FDA warns Ocean, NJ-based Flawless Beauty and Skin that it is illegally distributing imported medical devices used in skin care.
FDA warns Dupo, IL-based Sterling Pharmaceutical Services about CGMP and other violations in its production of finished drugs.
FDA starts the Split Real Time Application Review pilot program called for in the PDUFA 7 reauthorization.
The U.S. Supreme Court asks the government to weigh in on Tevas appeal of a court decision in a case involving a so-called skinny label for a generic ...
FDA says device makers can now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online throug...
FDA and other researchers tout the benefits of the accelerated approval pathway in precision oncology.
FDA publishes three guidances describing the effect on the review clock and goals of agency and industry actions in de novo, 510(k), and PMA submissio...
