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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 FDA awarded clinical trial grants, totaling more than $23 million over four years, for research on 21 rare diseases, including amyotrophic lateral sclerosis, brain tumors, cystic fibrosis and drug-resistant HIV. 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
Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos. Read More