News from the world
14
Jan
US FDA CDER’s work to help develop a nitrosamines acceptable intake limit approach
In the Spotlight on CDER Science, CDER experts work with international regulators to develop a methodology,...
China publishes guidelines in push to reform regulations by 2027
he Chinese government has published guidelines intended to accelerate the reform of drug and medical...
ndia’s CDSCO gives small manufacturers more time to comply with new GMP rules
India’s Central Drugs Standard Control Organization (CDSCO) has given small and medium scale manufacturers...
07
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
The U.S. Food and Drug Administration issued draft guidance to provide recommendations on the...
latest news
14 Jan
07 Jan
Batch uniformity: FDA details testing approaches for continuous manufacturing
03 Jan
FDA issues final guidance on advance manufacturing technologies designation program
31 Dec
CDMO sector looks to recovery in 2025 amid positive macro, industry trends
China to double down on biomanufacturing investment in 2025
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