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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June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC. OPDP reviewed a “Doctor […]
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May 23, 2020–The Food and Drug Administration’s (FDA’s) use of and reliance on advisory committees has declined sharply over the past decade, according to an analysis in the May 2020 issue of the journal Health Affairs. How – and how often – the FDA relies on input from advisory committees were among the issues raised […]
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Feb. 21, 2022 – During President Joe Biden’s first year in office, his administration’s health policy team has faltered, made missteps and miscalculations on COVID-19 decisions and communication, and took more than a year to secure a permanent Food and Drug Administration Commissioner (Robert Califf, M.D., was confirmed to take the helm on Feb. 15). […]
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By Michael Parenti, Senior Engagement Strategist, Saatchi & Saatchi Wellness Feb. 1, 2019 — On Oct. 25, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices […]
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