Ever wonder what the Regulatory Branch does? We asked several program and project managers and David Hibbs, chief, regulatory program branch, to tell us about the work they do; they do a lot that you ...
Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...
The FDA Regulatory Sciences and Entrepreneurship Program is a dynamic curricular initiative that bridges academia, industry, and regulatory agencies. Led by distinguished faculty, this ...
Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...
The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.
HORSHAM, PA, USA-DECEMBER 28, 2010-DIA today announced the launch of its Regulatory Affairs Certificate Program. The Regulatory Affairs Certificate Program is the fourth certificate program developed ...
JERUSALEM, March 26, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides, announced today that The American Society ...
Navigating the complex landscape of drug approval presents significant regulatory challenges, requiring a delicate balance between fostering pharmaceutical innovation and ensuring patient safety. The ...
FluoGuide A/S (STO:FLUO) ("FluoGuide" or the "Company"), a biotech company specializing in precision cancer surgery, announces changes to both its corporate management and Board of Directors to drive ...
Three years removed from Operation Warp Speed, which delivered a bevy of safe, effective COVID-19 vaccines, the Food and Drug Administration is taking those processes to put a greater spotlight on ...
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