Lance Shea

Lance Shea

BakerHostetler

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FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

3/4/2016 - Comment Period Cybersecurity Draft Guidance FDA Manufacturers Medical Devices NIST Risk Management

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

2/11/2016 - ANDA Antitrust Violations Biologics Clinical Laboratory Testing Corporate Counsel FDA Orphan Drugs Pharmaceutical Industry Pharmaceutical Patents Popular REMS Research and Development Young Lawyers

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 Industry 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 - FDA Healthcare Healthcare Reform Medical Devices Pharmaceutical Industry 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FDA Releases Unique Device Identification Final Rule, Draft Guidance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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