Search results
FDA clears Curio's postpartum depression PDT
NJBIZ· 9 minutes agoCurio Digital Therapeutics Inc.’s MamaLife Plus offers a nonpharmaceutical alternative to treating postpartum depression. Princeton-based Curio announced...
FDA Says It Will Take on Wider Regulation of Medical Tests. Is It Ready?
Bloomberg· 5 hours agoHi, it’s John in Boston. This week, the FDA signaled it may finally make a move that’s been on the...
Trade union’s legal challenge over Rwanda Act to be heard in June
Press Association News via AOL· 24 minutes agoThe FDA trade union’s High Court challenge over the Government’s Safety of Rwanda Act will be heard...
FDA finalizes lab developed test rule despite industry opposition
MedTech Dive via Yahoo Finance· 4 days agoThe rule amends agency regulations to make explicit that in vitro diagnostics are devices under the...
FDA approves Alecensa as leading-edge adjuvant therapy for ALK-positive lung cancer
Clinical Trials Arena via Yahoo Finance· 1 day agoOn 18 April 2024, the US Food and Drug Administration (FDA) approved Roche’s Alecensa (alectinib),...
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...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 20 hours 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 ...
FDA misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
TODAY via Yahoo News· 20 hours agoThe FDA announced it would propose a ban on formaldehyde commonly found in hair relaxers typically...
Biotech, Food & Drug
The National Law Review· 5 hours agoIn today’s hyper-aware environment, concerns about food and drug safety are paramount for both companies and consumers. The Food and Drug Administration (FDA) and the US Department ...
FDA Issues Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 1 day agoOn April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro...
