Anisa Mohanty
Subscribe to Anisa Mohanty's PostsAnisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Read Anisa Mohanty's full bio.
340B Covered Entities May See Access Changes to Contrast Media, Radiopharmaceuticals and Other Products
By Emily Jane Cook and Anisa Mohanty on Feb 2, 2023
Posted In 340B
340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023 is a new law requiring the US Food and Drug Administration (FDA) to treat all contrast media, radiopharmaceuticals and over-the-counter (OTC) monograph...
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FDA 2019 Year in Review
By Alva C. Mather, Anisa Mohanty, Michael Ryan and Vernessa T. Pollard on Jan 13, 2020
Posted In FDA, Life Sciences
2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir...
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Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies
By McDermott Will & Emery and Anisa Mohanty on Aug 22, 2019
Posted In FDA, Life Sciences
In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the...
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