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...