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Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is seeking suggestions on prescription drugs that would be exempt from EU safety authentication requirements and nonprescription drugs that should bear the safety feature. Read More
Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More
The FDA expects to have standardized formats for ANDA data submissions in place and required for all filers by the first half of fiscal year 2017. Read More
European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults. Read More
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