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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
Drugmakers, importers, marketers and distributors in India must report company details, production sources and product lists in an online database by next month, according to the country’s drug regulatory authority. Read More
Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency. Read More