JD Supra12m
FDA Guidance for Labeling Plant-based Products
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
The American Journal of Managed Care40m
Uniform Global Standards, Processes Could Accelerate CGT Approvals, Access
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
The Manila Times41m
FDA Issues Clearance for ReWalk 7 Exoskeleton
Seventh Generation of Industry-Leading Exoskeleton Includes New and Enhanced Features for Individuals with Spinal Cord Injury ...
Medscape2h
Do We Know Enough About Assisted Dying Drugs?
Amid the ethical and legal arguments, a fundamental question remains: How much do we truly understand about the drugs used in ...
B.C. doctors get new guidance on involuntary care for drug users
The guidance from Dr. Daniel Vigo, B.C.'s first chief scientific adviser for psychiatry, is aimed at helping clinicians and others decide when involuntary admission is appropriate for people with both ...
B.C. doctors get new guidance on involuntary care for people who use drugs
British Columbia clinicians have received new guidance about involuntary care for adults, including a directive that it cannot be used to prevent harmful "risk-taking" by people who use drugs whose ...
The BMJ14h
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
National Law Review15h
HHS Secretary Kennedy Directs FDA to Consider Eliminating Self-GRAS Determinations
Is this the start of RFK, Jr., making good on his promise to transform the food industry? Newly appointed Secretary of Health ...
JD Supra18h
Reminder: FDA Does, In Fact, Review DOF
FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...
Good Morning America19h
Compound versions of some weight loss drugs to be restricted
The FDA says state-licensed compounding pharmacies must immediately stop making compound versions of GLP-1 drugs. Larger, national licensed facilities making compound versions of Zepbound have until ...
Federal dietary guidelines will soon change for Americans, HHS and USDA announce
USDA Secretary Rollins and HHS Secretary Kennedy announced that they are reviewing the current Dietary Guidelines for Americans report, which will be changed and released this year.
Becker's ASC22h
FDA advances new drug application for ketamine
Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...