Timeline depicts the 27-year history of mifepristone from new drug application submission through an advisory committee vote, REMS changes, and legal challenges. With the product headed back to the Supreme Court, FDA's approval authority in general is also on the docket.
Mifepristone has had a tumultuous history since the US Food and Drug Administration approved the drug for medical termination of intrauterine pregnancy. Antiabortion groups have sought to restrict its use and have it removed from the market while medical groups have pushed the agency to make it more accessible.
The timeline below tracks mifepristone developments through the US Court of Appeals for the Fifth Circuit’s decision that would change mifepristone access back to the
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
