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17
Gen
WHO outlines best practices for continuous manufacturing
The World Health Organization has issued a draft document to guide the adoption of continuous manufacturing...
US FDA - Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications
In a Federal Register Notice published, FDA announced the establishment of a public docket and request...
Japanese Pharmacopoeia (JP18) - Translation of Supplement II just Released.
The Japanese Pharmacopoeia (JP) is a publication by the MinistryofHealth, Labour and Welfare (MHLW) in...
14
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,...
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17 Gen
14 Gen
China publishes guidelines in push to reform regulations by 2027
ndia’s CDSCO gives small manufacturers more time to comply with new GMP rules
07 Gen
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
Batch uniformity: FDA details testing approaches for continuous manufacturing
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