News dal mondo
07
Apr
Trump signs order imposing 100% tariff on patented pharmaceuticals, ingredients
Drug companies with Most Favored Nation pricing deals with the Trump administration are exempt, as are generic drugs, biosimilars, and related ingredients...[PharmaManufacturing]
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...
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US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics.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
23 Feb
USA . La Corte Suprema boccia i dazi globali di Trump: cosa cambia e perché il pharma resta nel mirino
20 Feb
NerPharma acquistata da un colosso farmaceutico francese
Generic industry against giving fee breaks to firms setting up operations in the US
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
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
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