Biotechnology manufacturer
Policy and implementation issues relating to Public Law No. 111-148, the Patient Protection and Affordable Care Act.
Policy and implementation issues relating to Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to the Prescription Drug User Fee program.
Current policy issues relating to Public Law No. 110-85, the Food and Drug Administration Amendments Act, specifically FDA's Risk Evaluation and Mitigation Strategy authority.
Policy issues relating to orphan drugs, dormant therapies and medicines for rare diseases; patient cost-sharing for specialty medicines; and step therapy.
H.R. 6, the 21st Century Cures Act.
H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act.
H.R. 2841, the Fair Access for Safe and Timely Generics Act.
H.R. 1600, the Patients Access to Treatments Act.
H.R. 2739, the Cancer Drug Coverage Parity Act.
S. 1566, the Cancer Drug Coverage Parity Act.
H.R. 3982, the Family Cord Blood Banking Act.
HCR - Health Issues
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BAKER & HOSTETLER LLP
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CHRIS JONES ADAM HIGGINS TYLER THOMPSON