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PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug...
Digital Journal· 15 hours agoFood and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. As...
FDA partners with other agencies to outline new plan for biotech product regulation
FierceBiotech· 2 days agoThe U.S. FDA, the Environmental Protection Agency and the Department of Agriculture have answered the Biden administration’s call to design a plan to overhaul biotech < ...
From Discretion to Regulation: FDA's New Path for LDTs | JD Supra
JD Supra· 3 days agoFood and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs.
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 11 hours agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
FDA Roundup: May 10, 2024
WDTN-TV 2 Dayton· 7 hours agoOn Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices ...
New bill introduced in Senate to reduce harmful toxins found in baby food
WJLA· 10 hours agoSenator Amy Klobuchar introduced a bill called the "Baby Food Safety Act” that could increase ...
New research reports on financial entanglements between FDA chiefs and the drug industry
Medical Xpress· 2 days agoRegulations prohibit FDA employees from holding financial interests in any FDA "significantly...
Earnings call: Guardant Health reports robust growth in Q1 2024 By Investing.com
Investing.com· 6 hours agoGuardant Health , Inc. (NASDAQ:GH) has announced its Q1 2024 financial results, showcasing a 31%...
It’s a Big Deal That the Government Is Rescheduling Marijuana. It’s Still Too Little, Too Late.
Slate via Yahoo News· 12 hours agoBut why bother? Marijuana’s lack of FDA approval means that even in the event that they manage to...
Califf wants adcomms revamped. Not everyone agrees.
Politico· 11 hours agoSTAT’s Helen Branswell dives into why H5N1 has continued to surprise public health experts since it emerged 27 years ago. The Department of Justice announced it is forming an antitrust division ...