Lance Shea

Lance Shea

BakerHostetler

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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FDA Releases Unique Device Identification Final Rule, Draft Guidance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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