The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. […]
The devices track will provide an overview and highlights of how to get a new medical device to market, discuss some best practices for ensuring that […]
The drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel […]
Docket Number: FDA-2021-D-1268 Issued by: Guidance Issuing Office Center for Veterinary Medicine Office of Regulatory Affairs Center for Food Safety and Applied Nutrition This guidance provides […]
Docket Number: FDA-2020-D-2316 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The intent of this guidance is […]
It should come as no surprise that when physicians speak out on social and political issues, there is sometimes a backlash. This can range from the […]
A lightbulb moment hit as Lawrence David was chatting one day with an ecologist who studies the microbiomes and diets of large herbivores in the African […]
A new study provides large-scale, population-level evidence that nuchal translucency (NT) screens detect a wide range of genetic disorders at thresholds lower than the level currently […]
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