Oluwaremilekun Mehner

Akin Gump Strauss Hauer & Feld LLP

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Latest Posts › Pharmaceutical Industry

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In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

1/17/2025 / Compliance , Drug Safety , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food Safety , Life Sciences , Pharmaceutical Industry , Public Health , Risk Assessment

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

4/4/2023 / De Novo Standard of Review , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

Updates in Co-Pay Assistance and Accumulators Litigation

Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more

12/3/2022 / Anti-Kickback Statute , Co-payments , Department of Health and Human Services (HHS) , Health Insurance , HIV , Insurance Industry , Medicare , OIG , Pfizer , Pharmaceutical Industry

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