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Federal Register notice: FDA reopens the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA ...[ Price : $8.95]
FDA says that all 53 new molecular entity approvals in 2020 were acted on by or before their user fee goal dates.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....[ Price : $8.95]
FDA issues a clinical hold on a Neoleukin Therapeutics Phase1 clinical trial of its immunotherapeutic candidate, NL-201, requestin...[ Price : $8.95]
CDER announces that a planned Office of Generic Drugs reorganization has been approved and will be implemented later this year.[ Price : $8.95]
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...[ Price : $8.95]
FDA alerts clinical laboratory staff and health care providers about the potential impact of viral mutations, including an emergin...[ Price : $8.95]
FDA continues its review of a Bristol-Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with...