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The FDA has awarded research grants totaling more than $19 million to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options. Read More
The U.S. government is awarding $62 million to Regeneron Pharmaceuticals and Inovio Pharmaceuticals to support their ongoing development of novel Ebola virus treatments. Read More
Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More
CDER Director Janet Woodcock came under fire Thursday from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More
The FDA has clarified prescribing information for antipsychotic drug clozapine, explaining how to monitor and manage treatment of patients with neutropenia. Read More
Drugmakers should notify the FDA and any affected trading partner within 24 hours of encountering suspected counterfeit products to prevent or limit them from entering or being distributed in the supply chain, the agency says in a notice published in Tuesday’s Federal Register. Read More
President Obama announced late Tuesday his intention to nominate Robert Califf as the next commissioner of the FDA, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More