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Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements | JD Supra
JD Supra· 7 days agoIn this Bulletin, we summarize the label requirements for cosmetics before and after MoCRA, offer our observations on recent developments, and provide an example of the rudimentary elements ...
FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
The Woonsocket Call· 3 days agoToday, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ...
FDA Updates Guidance on Intentional Genomic Alterations in Animals
The National Law Review· 3 days agoIntentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic...
FDA official sets out approach to AI in medical devices
MedTech Dive via Yahoo Finance· 5 days agoDeveloping quality assurance practices for AI models should be a priority, said Troy Tazbaz,...
Journal of Free Speech Law: "FDA Regulation of Physicians’ Professional Speech," by Prof. Barbara J....
Reason.com· 5 days agoOn September 28, 2022, after six years of effort and two draft guidance documents, the U.S. Food and Drug Administration (FDA) finalized its Guidance on Clinical Decision ...
At ASM Microbe, Clinical Microbiologists Question How to Implement FDA's LDT Rule
GenomeWeb News· 1 week agoIn May, the FDA issued a final rule in which it said that LDTs are in vitro diagnostics (IVDs) and that, as all IVDs are medical devices, they fall under the FDA& ...
In a first, FDA authorizes flavored e-cigarettes from Altria’s NJOY for sale in the US
WSAU Wausau· 2 days ago(Reuters) - The U.S. Food and Drug Administration authorized four of Altria's menthol e-cigarettes...
FDA Warns Yet Another Birth Tissue Company
MedPage Today· 3 days agoThe FDA has warned birth tissue company Neobiosis that its products derived from human amniotic fluid and umbilical cord are unapproved drugs. In its...
FDA Roundup: June 18, 2024
Rome Sentinel· 5 days agoToday, the FDA announced a request for input about patient safety associated with certain medical software functions excluded from the medical device definition. This input ...
4 Questions the US Supreme Court’s Abortion Pills Decision Didn’t Decide
National Catholic Register· 6 days agoThe limited abortion-pill decision of the U.S. Supreme Court June 13 leaves major questions about...
