Nicholas Manetto

Faegre Drinker Biddle & Reath LLP

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Outlook for the 2022 Federal Health Legislative Landscape

As the 117th Congress moves into its second legislative session, there is no shortage of health care policy issues dotting the landscape. The COVID-19 pandemic, legislative gridlock and a 2021 that was largely locked down by...more

1/11/2022 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medicaid , Medicare , PDUFA , Prescription Drugs , Telehealth , User Fees

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

FDA Advances Patient Engagement via PDUFA VII Performance Goals

On August 23, 2021, the Food and Drug Administration released the PDUFA VII commitment letter, which contains the agency’s performance goals for the five-year window (Fiscal Year 2023 to 2027) covered by the next iteration of...more

8/27/2021 / Food and Drug Administration (FDA) , PDUFA , Prescription Drugs , User Fees

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

6/24/2021 / Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Research , PDUFA , Public Health

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