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Dietary Guidelines Advisory Committee Submits Recommendations

On February 23, 2015, the Departments of Health and Human Services (HHS) and Agriculture (USDA) released the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (DGAC). ...more

UK Information Commissioner’s Office (ICO) Receives Power to Audit National Health Service

The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more

U.S. Supreme Court Denies Antitrust Protection for State Professional Boards

In a 6-3 decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission, the United States Supreme Court ruled today that state professional boards comprised of active professionals in the occupation...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FDA Issues Draft Guidance That Affects Health IT

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Restaurant Franchisors: Prepare to Comply With New FDA Menu Labeling Rules

The U.S. Food and Drug Administration (FDA) released its final rules for menu labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive health care reform...more

FDA Issues Much Anticipated Final Rules on Menu and Vending Machine Nutrition Labeling

The U.S. Food and Drug Administration (FDA) recently published the long awaited final rules on menu and vending machine nutrition labeling. The rules implement section 4205 of the Patient Protection and Affordable Care Act...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Prepare for Changes to CMS’ Five Star Quality Rating System for Nursing Homes

Choosing a nursing home can be a daunting task for consumers who often have myriad questions regarding the quality of care available at the nursing homes in their areas. To help answer these questions, CMS has created the...more

Medical Staff Bylaws: Compliance Gaps and Best Practices - Part 1

In this presentation: - Background - Definitions - Purposes/Preamble - Nature of Medical Staff Membership - Qualifications for Membership - Insurance...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Industry Critical of Proposed Prop 65 Regulations

The California Office of Environmental Health Hazard Assessment’s (OEHHA) 2014 proposed regulations to revise Proposition 65 warnings has been widely panned by industry critics. The overhaul was requested by Governor...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

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