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Apr
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 23 giugno 2026 [Federal Register Volume 91, Issue 72 - April 15, 2026]
US FDA GDUFA Reauthorization performance goals and program enhancements Riscal years 2023-2027 - Meeting 23 giugno 2026
[Federal Register Volume 91, Issue 72 - April 15, 2026]
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...
23
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...
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TGA clarifies therapeutic goods are unaffected by chemical production and import ban
20 Apr
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
Alfasigma cede a Fine Foods il 100% di Sofar
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