We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a notice today clarifying that any adverse event not included on a compounded drug’s labeling should be considered “unexpected” and reported to the agency. Read More
Manufacturers of new drugs and biologics, generics and biosimilars, as well as outsourcing facilities, will pay higher user fees for their applications starting Oct. 1, according to figures released Friday by the FDA. Read More
Baxter International is recalling one lot of IV solution over leakage, particulates and missing port protectors — the company’s eighth recall since December 2013 and the second in July. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released Friday. Read More
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015 as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More
United Therapeutics has filed suit in federal court in New Jersey, claiming Allergan’s Paragraph IV ANDA for a generic version of its hypertension drug Tyvaso violates three of the drug’s patents. Read More
A U.S. district court in Maryland has let stand the FDA’s November 2014 decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 from the FDA for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More