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India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Read More
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