FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions....
02 January, 2025
FDA
New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard
The recently proposed U.S. Food and Drug Administration (FDA) guidance updated the agency’s expectations for the contents of informed consent forms for clinical trial participants. ...
21 November, 2024
What’s Next for Psychedelic Medicines?
After the Food and Drug Administration’s recent decision to delay the approval of MDMA-assisted therapy for post-traumatic stress disorder, the path forward has become less straightforward for the field of psychedelic medicines....
30 October, 2024
Injectable drug to ease advanced Parkinson’s disease symptoms approved by FDA
The drug is a 24-hour infusion injected below the skin that treats motor fluctuations in patients with advanced Parkinsons....
17 October, 2024
Decentralized clinical trials back in the spotlight thanks to new FDA guidance
Two experts on regulatory and compliance trends weigh in on the FDA's recently issued guidance on decentralized clinical trials....
16 October, 2024
FDA perspective on the regulation of artificial intelligence in health care and biomedicine
A review of the FDA's regulation of artificial intelligence (AI) and the potential uses of AI in medical product development, clinical research, and clinical care....
15 October, 2024
Wisconsin is on the front lines of psychedelic research that could reach millions
Wisconsin scientists are among those conducting dozens of clinical trials worldwide on the use of psilocybin to treat depression. They say the evidence shows that, in combination with therapy, it shows great promise. ...
07 October, 2024
FDA Approves First Novel Drug for Schizophrenia in Decades
Xanomeline and trospium chloride (Cobenfy) has no boxed warnings...
27 September, 2024
Diversity Action Plans for Clinical Trials: Evaluating FDA’s Draft Guidance
The FDA is intent on improving the enrollment of participants -- also known as "subjects" -- from underrepresented populations in clinical studies for drugs and devices....
06 September, 2024
FDA Approves First Emergency Allergy Nasal Spray
The first non-injectable emergency treatment for allergies is anticipated to hit shelves following FDA approval of the Neffy epinephrine nasal spray. Neffy is a non-needle-based epinephrine treatment for anaphylaxis and other allergic reactions...
09 August, 2024