JD Supra1d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
GlobalData on MSN2d
Lundbeck gains FDA fast track designation for MSA therapy amlenetug
Lundbeck has received the US FDA fast track designation for amlenetug, a potential treatment for multiple system atrophy (MSA ...
technologynetworks3d
Enhancing Process and Parameter Control for Accelerated Time to Patient
This article explores how digital maturity in process design and parameter management can drive significant time and cost savings, streamline tech transfers and ultimately accelerate patient access to ...
Acsh.org3d
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer’s Disease
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s ...
CRISPR: From Discovery To Clinic—And Charting A Path Forward
No doubt 2025 will usher in many more advances in CRISPR therapies, thanks to the FDA’s new Platform Technology Designation ...
The American Journal of Managed Care2d
FDA Approves Mirdametinib for Neurofibromatosis Type 1 With Plexiform Neurofibromas
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
NKGen Biotech receives U.S. FDA FTD for troculeucel
NKGen Biotech (NKGN) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation, FTD, for the investigation ...
JD Supra1d
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
pharmaphorum2d
A well-kept secret: Applying IEPs to accelerate digital health commercial adoption
Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...
Ghana News Agency (GNA) on MSN3d
FDA leads 7 African regulators to foster trust and accelerate access to medicines
The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...