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News dal mondo

04

Nov

US CDER’s Work to Meet User Fee Goals During the Pandemic

One of the challenges facing FDA during the public health emergency is how to ensure timely reviews of applications for drugs and biological products despite a surge in work volume and practical constraints, such as travel limitations, quarantine and social distancing requirements or lockdowns. Americans depend on the agency to review and, when they meet our high scientific standards, approve medical products that are important to patients and health care professionals...[FDA]

18

Gen

AIFA - Gestione telematica istanze e atti emessi dall’Ufficio GMPMED. Avvio della I Fase dal 17 gennaio 2022

L’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (Ufficio GMPMED), allo scopo di ottimizzare...

14

Gen

“CEP of the future”: project update

The consultation phase of the project to design the Certificate of suitability to the monographs of...

13

Gen

Industry seeks delay for reporting manufacturing volume data

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up...

13

Gen

Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.


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