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The CMS List of Selected Drugs: Developing Effective Arguments for Pricing of Selected Drugs Under the Inflation Reduction Act of...

On Aug. 29, the Centers for Medicare & Medicaid Services (“CMS”) issued the inaugural list of drugs selected for price setting under the Inflation Reduction Act of 2022 (IRA). Those selected drugs are Eliquis, Jardiance,...more

BakerHostetler FDA and Pharmacy Weekly Digest

Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more

[Webinar] Pharmaceutical Life Cycle Management: Updates on Navigating the IP, FDA and Antitrust Terrain - April 5th, 12:00pm EST

There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

21st Century Cures Act Passes House Committee

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more

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