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FDA notifies NDA and ANDA holders about data integrity and study conduct concerns involving bioequivalence studies conducted at In...[ Price : $8.95]
FDA accepts for review a Liquidia NDA resubmission for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hyper...[ Price : $8.95]
FDA approves a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes ...[ Price : $8.95]
FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.[ Price : $8.95]
The Autism Self-Advocacy Network sharply criticizes HHS for hiring quack David Geier to study a potential link between autism and ...[ Price : $8.95]
A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Offi...[ Price : $8.95]
HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to cons...[ Price : $8.95]
An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of...