Derrick Gingery

Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make to the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.

Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump's potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS, and FDA Commissioner Robert Califf's request that industry help preserve the agency status quo.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump's controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.

Numerous staff positions at the US FDA could be the target of incoming administration efforts to remake the federal bureaucracy.

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission's search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program's costs.

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

President-elect Trump is backing a government funding bill that cuts pharma priorities, but it remains unclear whether the plan will garner enough votes to prevent a government shutdown.