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The FDA hit drugmaker Opto-Pharm with a warning letter, citing a lack of written procedures for preventing contamination of sterile drug products, as well as problems with validation, testing and labeling. Read More
The FDA has accepted for review the first two novel, personalized cancer treatments — known as chimeric antigen receptor T-cell therapies, or CAR-T — using immune system cells drawn from the blood and reprogrammed to target cancer cells. 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 response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. 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