Regulatory Affairs Professionals Society

FDA seeks feedback on quantitative medicine network

The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation ...
JD Supra

FDA Guidance, Clinical Pipelines, and the Emerging Deal Landscape of Psychedelic Therapeutics

Psychedelic drug development is moving from a largely experimental field toward a suddenly much more compelling ...
RAPS

Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations

The US Food and Drug Administration (FDA) on Friday issued draft guidance providing recommendations for sponsors looking to develop drugs to treat hypertension in patients already taking several other ...

First mRNA flu shot approved by FDA bodes well for improving drugs of the future – though a few hurdles remain before mRNA can move beyond vaccines

From COVID-19 vaccines to Moderna’s mRNA flu vaccine, using mRNA as medicine has shown promise. But before mRNA drugs can go ...

Splash Beverage Group Partners with Veteran Cannabinoid Drug-Development Team to Advance CannEpil® Through FDA Veterinary Pathway

Collaboration with Lupvindol Biosciences will initially target companion-animal oncology and chronic pain management Splash ...
JD Supra

AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...
STAT

FDA backs proposals to entice pharma companies to test, make drugs domestically

John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07. Lizzy leads STAT’s coverage of the ...
STAT

Biotech leaders say uncertainty at FDA threatens drug development

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.

FDA allows unique endpoint in rare disease study

Global regulators are allowing the company to use hospitalization as the primary efficacy endpoint in its registration trial ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...