Tag: accelerated approval

accelerated approval

Regulatory/FDA

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]

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Regulatory/FDA

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval pathway and Congress continues to push for action, the FDA’s Office of Prescription Drug Promotion (OPDP) is tackling one piece of the puzzle: How well consumers understand the limitations of accelerated approval drugs […]

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Legislative

House Shines Spotlight on Accelerated Approvals, May Tie Legislation to PDUFA

House Shines Spotlight on Accelerated Approvals, May Tie Legislation to PDUFA

March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held last week. While a slate of health-related bills for possible inclusion in the Prescription Drug User Fee Act (PDUFA VII) reauthorization package were discussed, the hearing led off with arguments […]

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Regulatory/FDA

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]

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Regulatory/FDA

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]

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Regulatory/FDA

Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel

Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel

May 6, 2021 – The outcome of a recent Advisory Committee meeting convened to review the uses of certain cancer drugs that were approved under the Food and Drug Administration’s (FDA’s) accelerated approval process sheds light on the potential pitfalls of the process after the approvals are granted. The FDA Oncologic Drugs Advisory Committee voted […]

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