The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...
Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...
On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore “Artificial Intelligence in Drug & Biological Product ...
In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...
When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...
Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...
Lee, MA, May 18, 2023 (GLOBE NEWSWIRE) -- RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, recently received FDA approval to begin Phase 1 clinical studies for an ...
(CNN) — In 1937, a drugmaker called S.E. Massengill Co. came up with what seemed like an improvement on an effective medicine for sore throats: a liquid formulation that tasted like raspberry. The ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
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