Draft Guidance

News & Analysis as of

Office for Human Research Protections Extends Comment Period for Draft Guidance

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance). Parties interested...more

CEQ Issues Draft Guidance on Evaluation of Greenhouse Gas Emissions

The guidance will significantly affect infrastructure projects located on federal land and federal permitting of major energy projects. On December 18, the White House’s Council on Environmental Quality (CEQ) issued...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Examination of Myriad-Mayo Guidance Comments -- The Coalition for 21st Century Medicine -- Part II

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Examination of Myriad-Mayo Guidance Comments -- The Coalition for 21st Century Medicine

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

International Bar Association Releases Guidance for Lawyers on the U.N. Guiding Principles

The Business and Human Rights Working Group of the International Bar Association (“IBA”) recently released draft guidance for bar association and business lawyers on implementation of the U.N. Guiding Principles on Business...more

FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more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FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities.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

Health Update - November 2014

“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA - Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more

NIST Draft Guide Advances the Debate on Cybersecurity Issues

Private sector entities looking to comment on the draft should focus on its recommendations surrounding sharing communities, standardized transfer mechanisms, and the handling of corporate legal considerations....more

FDA Posts New Materials on Proposed Laboratory Developed Test (LDT) Regulatory Framework

On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

Same Surgical Procedure Exception under 21 CFR 1271.15(b): FDA Raises More Questions Than it Answers Regarding the Scope of the...

The FDA has released a new draft guidance document for industry entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” (the Guidance Document), which...more

ESMA Consults on Uniform Definition of EU Commodity Derivatives

The consultation paper aims to clarify the classifications of derivatives and provide a consistent approach for entities operating across the EU. The European Securities and Markets Authority (ESMA) recently published...more

Latest News on European Patents

Europe has been bustling with recent news and development from the Unified Patent Court Preparatory Committee and the European Patent Office. New Draft UPC Rules of Procedure and UPC Status - The Preparatory...more

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

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

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