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FDA Roundup: May 03, 2024
KTLA-TV Los Angeles· 23 minutes agoToday, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development" for veterinary drug products. This draft ...
Orchard Software's Solutions Provide Support for Labs That Perform LDTs, Now Under FDA Oversight
KTLA-TV Los Angeles· 1 hour agoIn response to the April 29th U.S. Food & Drug Administration (FDA) Final Rule 21 CFR Part 809 Medical Devices: Laboratory Developed Tests (LDTs), Orchard Software is actively ...
FDA Says It Will Take on Wider Regulation of Medical Tests. Is It Ready?
Bloomberg· 10 hours agoHi, it’s John in Boston. This week, the FDA signaled it may finally make a move that’s been on the...
Weight loss drug shortage: Zepbound and Wegovy in short supply, says FDA
BenefitsPRO· 1 day agoThe U.S. Food and Drug Administration updated its drug shortage database in April to reflect that...
JD Supra: FDA's View on Cannabis
JD Supra· 3 hours agoThe U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first ...
FDA, doctors warn about compounded Ozempic
WFTV via Yahoo News· 3 days agoIt’s a popular drug that millions of people are taking to lose weight, but the federal government and doctors are warning users about some versions of...
Accord BioPharma, Inc. Announces FDA Approval of HERCESSI (trastuzumab-strf) | JD Supra
JD Supra· 13 hours agoOn April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf). HERCESSI is a biosimilar to HERCEPTIN ...
Charity launches legal action against Rwanda plan
Daily Telegraph· 2 hours agoThe FDA union said civil servants could be in violation of the civil service code – and open to possible prosecution – if they followed a minister’s...
FDA misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
TODAY via Yahoo News· 1 day agoThe FDA announced it would propose a ban on formaldehyde commonly found in hair relaxers typically...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 1 day agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests ...
