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A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More
The U.S. Food and Drug Administration’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
The Medicines and Healthcare products Regulatory Agency is considering charging devicemakers a fee for submissions required to confirm a product’s regulatory compliance. Read More
Manufacturers and importers of drug-eluting stents for the Indian market are coming under fire for allegedly conniving with distributors to hike prices and, in some cases, bribe doctors to use their products. Read More