Administrative Agency Health Consumer Protection

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FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two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FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms.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June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion.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FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar.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

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

FDA Issues Draft Guidance on Promotion on Internet and Social Media Platforms

On June 17, 2014, the FDA issued long-awaited draft guidance documents addressing two challenges related to use of social media to communicate about FDA regulated products: dissemination of information in character-limited...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Calorie Counts on Menus and Menu Boards to Be Mandatory for Ontario Franchises

On February 24, 2014, Ontario’s minority Liberal government introduced Bill 162, Making Healthier Choices Act, 2014. If passed, the legislation would require restaurant chains and other food service providers with 20 or more...more

Where There’s Smoke, There’s Proposed Regulation: FDA Seeks to Bring E-Cigarettes Within Its Regulatory Authority

On April 24, 2014, the Food and Drug Administration (“FDA”) released a proposed rule (the “Proposed Rule”) that will expand its authority to regulate items like electronic cigarettes (“e-cigarettes”). The Proposed Rule...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

What's in the Box? FDA Proposes Revisions to Nutrition Facts

On February 27, 2014, the U.S. Food and Drug Administration proposed three rules that would make landmark revisions to the iconic black and white Nutrition Facts panel if finalized. The proposed changes affect all packaged...more

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more

The HIPAA/HITECH Final Rule Has Been Released

The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more

Brace for Impact – Final HITECH Rules Will Require Substantially More Breach Reporting

HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more

First HHS OCR Settlement for HIPAA Breach Involving Less Than 500 Patients Sends Message to Providers

On January 2, 2013, HHS announced that the Hospice of North Idaho (HONI) agreed to pay $50,000 and enter into a Corrective Action Plan (CAP) as part of a settlement involving a breach of unsecured electronic protected health...more

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

On January 2, 2013, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential HIPAA violations....more

De-Identifying Protected Health Information: OCR Issues Long-Awaited Guidance

The HIPAA Privacy Rule is intended to protect individually identifiable health information by limiting its use and disclosure. But the Privacy Rule expressly permits the de-identification of that information, and in doing so...more

First HIPAA Breach Settlement Involving Less Than 500 Patients Announced

ALL PROVIDERS ARE OFFICIALLY ON NOTICE. In a move that signals just how seriously the federal government is taking its enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S....more

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