US Pharma MarketingWhen is one trial enough? Drugmakers push FDA for greater clarity on draft guidance
argenx, Ultragenyx, UCB, PhRMA and BIO push FDA for clearer rules on when one pivotal trial plus confirmatory evidence can support approval. Topic Hubs AI drug discovery: News, analysis and interviews Antibody-drug conjugates: The next wave of targeted cancer drugs Biopharma M&A and dealmaking: Who’s buying and why Biopharma people moves: CEO changes, executive hires, board positions Biotech IPOs: Tracking the market for new public offerings Biotech venture funding: Who’s raising and where the money is going Cell and gene therapy manufacturing: Scaling the next frontier China biotech: Licensing deals and the Biosecure Act CRISPR and gene editing: The push…
Pharmaceutical companies and industry groups are calling on the FDA to provide more details and examples about when sponsors can rely on one pivotal trial plus confirmatory evidence for a new drug’s approval.
The push ...
Source: Endpoints News