Draft Guidance

News & Analysis as of

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

FDA Regulatory and Compliance Monthly Recap — August 2015

OPDP warns Duchesnay over Kim Kardashian’s social media endorsement of morning sickness drug - The regulator issued a warning letter stating Kardashian’s endorsement of the company’s Diclegis pill on social media was...more

FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products....more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

The American Bar Association Joins Growing Chorus Of Groups Raising Concerns About Fair Pay And Safe Workplaces Regulations

On August 26, 2015, the Section of Public Contract Law of the American Bar Association (“ABA”) submitted public comments to the General Services Administration (“GSA”) and the U.S. Department of Labor (“DOL”) on their...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

EPA Issues Draft Guidance on Pesticide Cumulative Risk Assessment: Framework for Screening Analysis

The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015. ...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for...

On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more

USCIS Releases Draft EB-5 Policy Guidance Clarifying Immigration and Project Related Issues Raised by Retrogression

Popularity of the EB-5 Immigrant Investor Program has surged in recent years among foreign investors from mainland China. As a result, the demand for EB-5 visas by foreign investors born in mainland China has exceeded total...more

Weekly Update Newsletter - August 2015 #2

GOVERNMENT CONTRACTS - DOD Issues Report Entitled Defense Contracts: DOD’s Request for Information from Contractors to Assess Prices - The Department of Defense (DOD) has issued a report entitled Defense Contracts:...more

For The Second Time, DOL And FAR Council Extend Notice and Comment Period For Guidance And Regulations Implementing The Fair Pay...

On August 5, 2015, the U.S. Department of Labor (“DOL”) published an announcement in the Federal Register informing the public that both it and the FAR Council have extended the notice and comment period for the proposed...more

Final USCIS Guidance on When to File Amended H-1B Petitions for Worksite Changes

As previously reported, on May 22, 2015, U.S. Citizenship and Immigration Services (USCIS) posted draft guidance on when to file an amended H-1B petition after the decision in Matter of Simeio Solutions. On July 21, 2015,...more

Employers Beware: If You Moved an H-1B Worker Without Advising USCIS, You Have Until August 19, 2015 to Make Amends

A recent binding decision issued by the Administrative Appeals Office (AAO) has complicated even further the confusing rules governing employer obligations in the H-1B nonimmigrant visa program. Part of U.S....more

Analysis of the Federal Acquisition Regulatory Council’s Proposed Rule to Implement Executive Order 13673 “Fair Pay and Safe...

On May 27, 2015, the Defense Department, General Services Administration and National Aeronautics and Space Administration announced the Federal Acquisition Regulatory Council’s proposed rule to implement Executive Order...more

DOL Invites Comments on Requirement That Bidders Disclose Employment Law Violations

President Obama’s Executive Order 13673, called the Fair Pay and Safe Workplaces Order, uses the prospect of gaining or losing an edge in winning government contracts to provide a powerful incentive for employers to comply...more

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

Agencies Finalize Diversity Policy Statement

On June 9, six federal agencies – the Federal Reserve, CFPB, FDIC, NCUA, OCC, and the SEC – issued a final interagency policy statement creating guidelines for assessing the diversity policies and practices of the entities...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

FDA Issues Draft Guidance for Mandatory Recall Authority

On Thursday, May 7, 2015, the FDA released draft guidance on the implementation of its mandatory recall authority. The guidance itself is not binding on food companies, but provides more information about the FDA’s recall...more

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more

Washington Healthcare Update

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

USCIS on Amended H-1B Petitions for Change in Work Location

As previously reported, on April 9, 2015, the Administrative Appeals Office (AAO), which is responsible for the review of certain decisions rendered by U.S. Citizenship and Immigration Services (USCIS), issued a published...more

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

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