Draft Guidance

News & Analysis as of

Advertising Law - Oct 2014

FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

SEVP Draft Guidance on Pathway Programs

On September 26, 2014, Immigration and Customs Enforcement Student and Exchange Visitor Program (SEVP) posted draft guidance on pathway programs, seeking comment from stakeholders. It is the third in a series of related...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

IRS releases final LIHTC Audit Technique Guide

Yesterday the IRS released a long-anticipated update to its Audit Technique Guide for the low-income housing tax credit (“LIHTC”) program. The guide is intended to assist IRS examiners charged with auditing owners of LIHTC...more

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more

Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions

Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Saudi Capital Market Authority Publishes Draft Rules for Qualified Foreign Financial Institutions Investment in Listed Shares

Following last month’s announcement by the Saudi Arabian Capital Market Authority (the CMA) of its proposal to permit participation by qualified financial institutions directly on the Kingdom’s stock exchange (the Tadawul),...more

SEVP Draft Policy Guidance on Conditional Admission, the Form I-20, and English Proficiency

The Immigration and Customs Enforcement (“ICE”) Student and Exchange Visitor Program (“SEVP”) issued draft guidance clarifying issues related to the appropriate issuance of the Form I-20, "Certificate of Eligibility for...more

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

What’s an MDDS? And Why Should I Care?

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...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

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

BVI publishes draft FATCA Guidance Notes

In the latest moves towards implementation of the FATCA Intergovernmental agreements (IGAs) signed by the BVI with the US and the UK, the BVI Government has released draft Guidance Notes for public consultation. A copy can be...more

Department of Education Issues Guidance on Changes to Clery Act Reporting Procedures and Requirements

On July 14, 2014, the U.S. Department of Education (DOE) issued important guidance to colleges and universities on their responsibilities to comply with changes to the Clery Act made by the amendment to the Violence Against...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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