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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
Next month, voters in California will decide on Proposition 61, which is intended to lower prescription drug prices, but veterans organizations oppose the initiative, saying it will raise drug prices for veterans. Read More
The European Medicines Agency is encouraging global regulators to collaborate on life science initiatives after a review of international projects found that several countries pursue common goals without sharing resources or information. Read More