Administrative Agency Consumer Protection Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

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FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media.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FDA Issues Final Nanotechnology Guidances and Draft Guidance for Comment

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices.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FDA Issues Draft Guidance on Promotion on Internet and Social Media Platforms

On June 17, 2014, the FDA issued long-awaited draft guidance documents addressing two challenges related to use of social media to communicate about FDA regulated products: dissemination of information in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FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices.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

Protecting Drug Supply Chain Security

Millions of Americans take prescription drugs every day while assuming that those drugs are what they purport to be, that they have not been tampered with, and certainly that they are not counterfeit. The validity of those...more

Changes Coming To Prescription Drug Advertising

FDA Developing New Risk and Benefit Perception Scale - On April 21, 2014, continuing its scrutiny of the disclosures of risks and benefits in prescription drug advertising, FDA announced a plan to conduct a study...more

SEC Cybersecurity Initiative: Five Steps ALL Broker-Dealers and Investment Advisers Should be Taking

Last week, the U.S. Securities and Exchange Commission’s Office of Compliance Inspections and Examinations (OCIE) released a Risk Alert announcing its Cybersecurity Initiative....more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...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

Intimate Images & Cyberbullying – Assessing The Canadian Response

Earlier this week, the Canadian government introduced Bill C-13, Protecting Canadians from Online Crime Act. The proposed legislation covers a lot of ground, including the introduction of a suite of new investigation powers...more

Has the FTC Met Its Match?

Companies across the Country should be following the Federal Trade Commission’s (“FTC”) civil suit brought against Wyndham Worldwide Corporation and Wyndham Hotels and Resorts, LLC (“Wyndham”) entitled Federal Trade...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

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

DOE Boldly Goes Where It’s Not Allowed

In an astonishing display of chutzpah, the Department of Energy has proposed to regulate computer servers as “consumer products” (link). Only in a bureaucrat’s mind could a computer server be considered a consumer product...more

Wyndham Case Challenges FTC’s Authority Over Cybersecurity

Over the past decade the Federal Trade Commission has brought cybersecurity enforcement actions against various private companies, imposing tens of millions of dollars in monetary penalties and requiring companies to maintain...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

109 Results
|
View per page
Page: of 5

Follow Administrative Agency Updates on: