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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...
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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The U.S. Food and Drug Administration issued draft guidance to provide recommendations on the...
le ultime news
04 Nov
Teva multata dalla Commissione europea per aver ostacolato un farmaco concorrente contro la sclerosi multipla
28 Ott
EDMQ - Removal of expiry notifications from the EDQM DCEP Sharing Tool
24 Ott
US FDA - DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
23 Ott
AIFA - Chiarimenti sui requisiti degli studi di extractables e/o leachables
18 Ott
US FDA - Final Guidance on Drug Master Files in Advance of Certain ANDAs
17 Ott
Farmaci, Italia punta su biotecnologie
16 Ott
US FDA - Requests for Reconsideration at the Division Level Under GDUFA
15 Ott
Lundbeck acquisterà Longboard Pharma
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