News from the world
31
Jul
FDA unveils FY 2027 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends...[US FDA - Federal Register]
18
Sep
EU Biotech ACT - Ue in ritardo sui farmaci biotech, sempre più ampio il gap con USA
È quanto emerso in un incontro svolto nei giorni scorsi a Bruxelles tra alcuni parlamentari europei...
18
Sep
Innovation & Pharma: The Molecules & Companies
How truly innovative is the bio/pharma industry? What products, modalities, and companies are behind...
18
Sep
US FDA Launches Pilot To Expedite INDs
FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications...
16
Sep
AIFA - Consultazione pubblica per definire i criteri per l’inserimento delle confezioni dei farmaci nell’elenco delle carenze “critiche”
a Legge n. 182/2025 (“Legge Semplificazioni 2025”) ha riformato il sistema sanzionatorio...
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10 Aug
EMA issues updated guidance on shortage prevention plans ahead of legal deadline
03 Aug
Destiniamo parte dei fondi per la difesa alla produzione di farmaci fuori brevetto
31 Jul
FDA unveils FY 2027 user fee rates
29 Jul
Esenzione sui dazi per taluni prodotti provenienti dagli USA
17 Jul
Inside Pharma’s Push for More Resilient Supply Chains
17 Jul
US FDA CDER plans new guidance on AI, electronic safety report submissions, and more
16 Jul
EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
15 Jul
Riforma farmaceutica. Via libera della Commissione Sanità del Senato