News dal mondo
30
Apr
AIFA pubblica il Terzo Position Paper sui farmaci biosimilari
È online il terzo Position Paper AIFA sui farmaci biosimilari. L’aggiornamento del documento...
29
US GDUFA IV Talks Reach Tentative Agreement; America First Application Fee Waiver Added
US FDA GDUFA Reauthorization performance goals and program enhancements Riscal years 2023-2027 - Meeting...
28
Sun Pharma compra Organon
Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...
27
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity...
le ultime news
11 Feb
AIFA - Aggiornamento della Nota esplicativa relativa alla procedura del “silenzio/assenso” in accordo con la nuova EC Classification Guideline sulle variazioni
AIFA - Nuova modalità Multi-Beneficiario per i pagamenti online delle tariffe previste dal D.M. 6 dicembre 2016
09 Feb
Pharma expert discusses effort to standardize CMC quality information
06 Feb
US FDA proposes waiving GDUFA facility fees for domestic manufacturers
Computer Software Assurance for Production and Quality Management System Software
04 Feb
FDA, EMA officials encourage companies to pilot eCTD 4.0
03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
02 Feb
USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
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