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.
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science. Read More
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of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released Friday.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