News from the world
17
Jan
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,...
latest news
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
20 Dec
AIFA - Processi e le interazioni con gli uffici dell’Area Autorizzazioni Medicinali: Report follow up 2024
18 Dec
PIC/S - Adoption and Entry into force of Guidance Documents on Remote Assessments
ICH Q9(R1) Risk Management Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers
17 Dec
AIFA - Nuove disposizioni applicative e modalità di attuazione delle variazioni all’AIC
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