HHS lays groundwork for new FDA rule on releasing the CRLs
Trump administration pushes the FDA to formalize its release of drug rejection letters via new rulemaking, with DTC ad and Phase 1 rules also on the agenda. 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…
The Trump administration is pushing the FDA to cement the details behind its proactive public release of rejection letters sent to pharma companies.
The rulemaking would clarify a policy that initially
Source: Endpoints News