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Focus on Regulation

Tag Archives: Health

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. Read More:  When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

National Health IT Week at the FCC

This week the Federal Communications Commission’s (FCC’s) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using broadband deployment to accelerate the adoption of advanced healthcare technologies, is joining more than 400 other public and private organizations in recognizing National Health IT Week (NHIT week).  NHIT week is a series of

Faster FDA Approval for Medical Devices Coming Soon

In April the U.S. Food and Drug Administration released two draft guidance documents related to premarket approval applications for medical devices. The first outlined an Expedited Access PMA program, building off the earlier pilot Innovation Pathway program. The second addressed the FDA’s plans for balancing premarket and postmarket data collection efforts. Both forms of guidance

HHS-OIG Proposes Significant Amendments to Exclusion and Civil Monetary Penalties Regulations

In the span of three days, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published two proposed rules in the Federal Register that substantially modify OIG’s exclusion and Civil Monetary Penalty (CMP) authorities. Below we summarize the major provisions of each proposed rule. Read More: HHS-OIG Proposes Significant

French sunshine regulations: publication of the governmental order on the unique public website managed by the French authorities

The governmental order on the unique public website set up under the French sunshine regulations was published today. The order provides details on this website, managed by the French authorities, which will make available to the public the information to be reported by the industry under the sunshine regulations.

House Judiciary Subcommittee Hears Testimony on the Impact of the Affordable Care Act on Health Care Competition

A mere two weeks before the health insurance marketplaces created by the Patient Protection and Affordable Care Act (“ACA”) are scheduled to open for enrollment, the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the House Committee on the Judiciary heard testimony on the effect of the ACA on health care competition. Representatives from

The Australian pharmaceutical industry association introduces self-regulation requirement to disclose payments to healthcare professionals and consumer organisations

On 5 July 2012, Medicines Australia, the pharmaceutical industry association in Australia, announced the adoption of its new Code of Conduct. Although the Code is not legally binding, it reflects a growing tendency, partly legislative in nature and partly through industry self-regulation, to promote transparency in relationships between the pharmaceutical industry and healthcare professionals and