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 EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic Research Labs’ facilities in India. Read More
More than a dozen state pharmacy regulatory authorities told the GAO they have trouble communicating with the FDA on drug compounding issues. Read More
China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical marketing. Read More
In a regulatory science update to Congress, the FDA cited its successes with the use of specialized consortia and improvements in clinical evaluation. Read More
Democrats in the House and Senate are seeking support for a proposal aimed at bringing down prescription drug prices — compiling ideas proposed in separate bills since the start of the year, including government negotiations and allowing importation. Read More
FDA Commissioner nominee Scott Gottlieb will recuse himself for one year from decisions relating to more than 20 companies, including large drugmakers, according to his ethics disclosure form. Read More