News dal mondo
04
Mar
ECHA’s Risk Assessment Committee adopts its opinion on PFAS restriction proposal
The European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) has concluded its evaluation of the universal restriction proposal on all per- and polyfluoroalkyl substances (PFAS). Its opinion is the first part of ECHA’s two-committee scientific evaluation of the proposal...[ECHA]
23
Apr
Top Drugs at Risk of Supply Shortages
Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...
Regulatory considerations for pharmaceutical excipient selection
The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...
21
TGA clarifies therapeutic goods are unaffected by chemical production and import ban
TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...
20
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...
le ultime news
06 Feb
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.
29 Gen
US FDA Announces PreCheck Implementation Roadmap
28 Gen
Industry wants more streamlining following recent EU reforms
FDA official offers tips on leveraging AI in drug manufacturing
Testo unico legislazione farmaceutica. La delega torna a Palazzo Chigi
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