FDA

The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.

The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.

As the US biosimilars market approaches the end of its first decade, it has seen another busy year, with Amgen’s surprise launch of a rival to Eylea shaking up expectations as other first-time approvals rolled in throughout 2024. Meanwhile, competition to Stelara is waiting in the wings from the start of 2025.

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

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

“MoCRA confirms in many ways FDA’s adherence to a risk-based cosmetics regulatory framework, and in that way, it’s very positive,” says Francine Lamoriello, global strategies executive vice president at the Personal Care Products Council.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

CRN suggestion that FDA prioritize facility inspections on firms which haven’t been cleared in third-party audits apparently has support at agency. But FDA hasn’t been receptive to adjusting its policy on precluding from use as dietary ingredients any substance studied or approved as a drug.