Lance Shea

Lance Shea


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House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

7/21/2015 - 21st Century Cures Initiative FDA Healthcare Medicaid Medicaid Reimbursements Medical Devices Medical Research Medicare NIH Physician Medicare Reimbursements Prescription Drugs

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

6/8/2015 - 21st Century Cures Initiative FDA Healthcare Medical Devices NIH Pending Legislation Pharmaceutical Pharmaceutical Manufacturers Sunshine Act

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

2/16/2015 - Drug Manufacturers FDA Healthcare Healthcare Reform Medical Devices Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Legislation

FDA Releases Unique Device Identification Final Rule, Draft Guidance

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

10/18/2013 - FDA Medical Devices Unique Device Identifiers

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