FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease
Senator Romney (R-UT) today led his Foreign Relations Committee colleagues in a letter to the Drug Enforcement Administration (DEA) Administrator Anne Milgram highlighting concerns over…
Medical Devices: Laboratory Developed Tests
The ban, originally anticipated last summer, has been held up over fears President Biden could lose support by banning products popular in the Black community.
The prevalence of H5N1 genetic material in purchased milk products suggests the bird flu outbreak is far more widespread in cows than official counts indicate.
This JAMA Forum discusses the US Food and Drug Administration’s efforts to implement the 2009 Family Smoking Prevention and Tobacco Control Act through approval of…
Family Unfriendly: How Our Culture Made Raising Kids Much Harder Than It Needs to Be
A group of nearly 70 House Republicans led by Rep. Richard Hudson (R-NC) pressed the president to move forward with long-pending applications for new smoke-free…
The Conservative Futurist: How to Create the Sci-Fi World We Were Promised
On September 29, 2023, FDA issued its much-anticipated proposed rule to regulate laboratory-developed tests as medical devices. If enacted as proposed, the rule will have…
The FDA will increasingly use accelerated approval for gene therapies aimed at rare conditions, according to Peter Marks, the FDA’s top official overseeing cell and…
