Tag: Dr. Robert Califf

Dr. Robert Califf

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FDA Proposes Increased Consumer Access to Nonprescription Drugs, with Conditions

FDA Proposes Increased Consumer Access to Nonprescription Drugs, with Conditions

July 11, 2022 – Providing a new pathway for drug companies and consumers that would enable additional drugs to become available without a prescription is the goal of a recent proposed rule from the Food and Drug Administration (FDA). The proposed rule, issued on June 28, would allow the FDA to approve nonprescription drug products […]

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Regulatory/FDA

Myers: Data Will Drive Califf’s Decisions at FDA

Myers: Data Will Drive Califf’s Decisions at FDA

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]

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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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