A Tufts Center for the Study of Drug Development analysis shows the financial and other benefits of decentralized clinical trials.
FDA issues the 2021 drug safety priorities report, the seventh in a series highlighting CDER and FDA drug safety activities.
The trade associations for branded and generic drugs urge the U.S. Trade Representative to use the 2022 Section 301 review to take steps to protect Am...
Federal Register notice: FDA withdraws approval of 29 NDAs from multiple applicants because they are no longer marketed.
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they notified the agency that the drug products were no ...
FDA approves a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroi...
The Justice Department says whistleblowers will receive about $2.6 million from a $13 million Cardinal Health settlement of charges it violated the an...
CDER releases a list of 98 new and revised draft guidances intended for publication in 2022.