Office of New Drugs Director Jenkins provides a peek into the Medical Policy Council’s efforts to consistently interpret and implement the ‘breakthrough therapy’ program.
All “breakthrough therapy” designation requests for products regulated by the Center for Drug Evaluation and Research are evaluated by the center’s Medical Policy Council.
The council provides a senior-level forum for establishing medical policy in the center and ensuring consistent application across review divisions Also see "CDER Medical Policy Council Balances “Breakthrough” Requests...
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.
Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
