Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.
Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.
Pink Sheet reporter and editors discuss the FDA’s plans to undo a previous reorganization and make facility and other inspectors generalists again, as well as industry efforts to adapt to the new direct-to-consumer advertising landscape.
Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than the FDA.
Pink Sheet reporter and editors discuss the issues that could arise for the FDA as it navigates the government shutdown, as well as the aftershocks of Pfizer’s drug pricing deal with the White House.
Pink Sheet reporter and editors discuss the FDA’s decision to remove the “adequate provision” loophole in its advertising regulations and other pharma industry issues that emerged from the Make America Health Again Commission report.
Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
