Axios on MSN4h
Drug price talks provide an early test for Trump
The Biden administration within days is expected to select the next batch of drugs that will be subject to Medicare price ...
BioSpace1d
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...
JD Supra23h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
BlackDoctor1d
4 Types of Clinical Trials and How They Work
Learn about clinical trials, from preclinical studies to Phase IV trials. Explore the different clinical trial phases (I-III) ...
Quality Assurance1d
FDA Issues Final Guidance on Action Levels for Lead in Processed Food Intended for Babies, Young Children
The final guidance covers packaged processed foods that are represented or purported to be for babies and young children less ...
Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...
BioSpace2d
All About Speed: Lilly Drives Innovation With New Facility to Help Bring Medicines to Market
Eli Lilly and Company has invested more than $20 billion in its manufacturing capabilities since 2020 to help meet high ...
The Circular Ring 2 is here and it beats the Oura Ring in two big ways
This level of longevity puts the Ring 2 in the same camp as the Oura Ring 4 and Samsung Galaxy Ring. The Circular Ring 2 also ...
JD Supra11d
FDA's Proposed Interim Animal Food Ingredient Consultation process - will the GRAS be Greener post-AAFCO Ingredient Definition Process?
October 1st has come and gone, with no final, established process that animal feed manufacturers and developers can rely on to determine whether a new additive is FDA-approved or, otherwise ...
CBS News11d
FDA proposes new tests to detect asbestos in cosmetics and other products containing talc
which passed legislation requiring the FDA take action last year. A known human carcinogen, asbestos is found in the same rock types as talc deposits and may mingle in the mining process ...