US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way
Longstanding compliance policy program aimed at getting marketed but unapproved drugs through the NDA/ANDA pathway is reinstated because its termination by the Trump Administration was ‘legally and factually inaccurate’; some experts want FDA to consider program’s impact on drug pricing as it re-establishes the initiative.
You may also be interested in...
Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
Not So Fast: Trump Team Paints US FDA Review Times As Too Slow
New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.
Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule
Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.