Lauren Bloch

Faegre Drinker Biddle & Reath LLP

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Three New Prescription Drug Innovation Models Latest Action on Drug Pricing

As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more

2/17/2023 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Lawmakers Introduce Cures 2.0 Legislation

Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more

11/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , PDUFA , Pharmaceutical Industry

Patient Perspectives—There’s an App for That!

On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more

11/12/2018 / Food and Drug Administration (FDA) , Health Care Providers , Mobile Health Apps , Pharmaceutical Industry

How Might the FDA's Proposed Patient Affairs Office Impact Patient Advocacy Efforts?

Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was...more

3/29/2017 / Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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