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Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA will continue to combat abuse of central nervous system-stimulating drugs like Ritalin and Adderall on a case-by-case basis, the agency said, rejecting a long-standing citizen petition that had called for a reformulation of the entire drug class. Read More
Sponsors developing therapies for rare pediatric diseases must pay the FDA roughly $2.6 million to use a priority review voucher in the new fiscal year that starts today. Read More
Regulators in Japan have proposed changes to the standards for using biological ingredients during the manufacture of pharmaceuticals, quasi-drugs and medical devices. Read More
The FDA is requiring new cardiac and cerebral warnings for Genentech’s asthma drug Xolair, based on an evaluation of long-term safety data, but the agency stopped short of mandating the strictest black box warning. Read More
Patients will be invited to participate in scientific discussions on the benefits and risks of certain drugs in Europe, under a new European Medicines Agency pilot project. Read More
Clinical studies to evaluate drugs treating irritable bowel syndrome (IBS) should involve patients experiencing recurrent abdominal pain or discomfort at least three days per month in the previous 90 days, according to new final guidance issued by the European Medicines Agency. Read More