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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
Switzerland’s Novartis is shuttering several of its research operations in Switzerland and China, eliminating 175 jobs, in an effort to centralize control of its drug discovery programs and curb costs. Read More