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The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018. Read More
The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More
The FDA is clearing up confusion on prior approval supplements for ANDAs, providing clarifications on reconsiderations and submissions in a final guidance document. Read More
The EMA has recommended that three medicines manufactured by Pharmaceuticals International no longer be available in the EU due to possible cross-contamination. Read More
A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More