The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders.
On September 22, 2023, the US...more
The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress.
Key Points:
..Congress authorized FDA to...more
Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines.
Key Points:
..Congress authorized FDA to collect increased total annual user...more