The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs ...
is meant to give patients early access to promising drugs . But how often do these drugs actually improve or extend patients’ lives?
The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs.It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval.
The research was published in the Journal of the American Medical Association and discussed at the American Association for Cancer Research annual meeting in San Diego on Sunday. The changes allow the agency “to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly,” FDA spokesperson Cherie Duvall-Jones wrote in an email. The FDA can now require that a confirmatory trial be underway when it grants preliminary approval, which speeds up the process of verifying whether a drug works, she said.
Canadian Dental Association president Heather Carr says her colleagues are 'hopeful' the new federal dental care program will mean better care for more Canadians, but the rollout has included 'a great deal of confusion and a great deal of complications' for dentists and patients. Parents around the globe love their kids the same, but there are some big differences in the way we treat them and the lens through which we view parenting as a whole.Opinion: I've covered California's homeless since before the word was used. This is what I learned
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