The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency’s backlog of orphan drug designation requests. The plan comes a week after FDA Commissioner ...
The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
Outlook Therapeutics (OTLK) announced that the FDA has issued a complete response letter to the ONS-5010/Lytenava biologics license application ...
The U.S. Food and Drug Administration announced yesterday that it has formed a panel of experts to help understand new technology in medical devices, according to a Reuters report. The FDA hopes this ...
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