News from the world
09
Mar
US FDA drafts guidance on best practices for responding to inspection observations
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections. FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection. This guidance applies to both domestic and international inspections.
FDA is accepting comments on the draft guidance on www.regulations.gov under docket number FDA-2025-D-1504 through 6 May...[FDA]
10
Apr
“Difenderemo il farmaco made in Italy” - Sottosegretario alla Salute Gemmato: Dal payback alla dipendenza da India e Cina
“Mitigare il payback” che pagano le aziende farmaceutiche per rendere più attrattivo...
Contract manufacturing deals for drugs marketed in US shift to Europe
Biopharma companies are increasingly choosing to outsource manufacturing for the U.S. market to European...
AIFA rafforza il dialogo con gli stakeholder: approvati due nuovi regolamenti
I Regolamenti di AIFA Ascolta e AIFA Incontra sono stati approvati in via definitiva e pubblicati sulla...
US-Iran ceasefire provides potential relief for pharma logistics, cost structures
Rising oil prices and disrupted shipping routes drove up costs, delaying sensitive shipments, and forcing...
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10 Apr
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Trump signs order imposing 100% tariff on patented pharmaceuticals, ingredients
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