Draft Guidance

News & Analysis as of

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Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more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In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

FDA Issues Draft Guidance for Mandatory Recall Authority

On Thursday, May 7, 2015, the FDA released draft guidance on the implementation of its mandatory recall authority.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FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more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FDA releases additional draft guidance regarding implementation of BPCIA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

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...more

Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA Today

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA’s current statutory framework and regulations do not permit compounding of animal drugs from bulk drug...more

NEPA Revised Draft Guidance on Consideration of GHG Emissions: Version 2.0 - Proposal Requires Federal Agencies to Assess GHG and...

Nearly five years after issuing its initial draft, the White House Council on Environmental Quality (CEQ) continues to revise its draft guidance on conducting greenhouse gas (GHG) impact analyses under the National...more

Is There Any End to Post-Closure Care Under RCRA?

Late last month EPA issued draft guidance on adjusting post-closure periods under RCRA. It’s not good news. ...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

Update: Germany's Draft Bill on IT Security

On March 20, 2015, the revised bill to increase the security of IT systems (the "Draft Bill")was first read in the German Bundestag. As contemplated in the White & Case Technology Newsflash of August 2014, the overarching...more

USCIS Proposes: L-1B Adjudications Policy

The Key – Applying the “Preponderance of the Evidence” standard”? Immigration practitioners are trying to figure out what to make of the proposed Policy Memorandum on L-1B Adjudications Policy (hereinafter “Guidance”)...more

Protecting food industry innovations as the scope of patentable subject matter narrows

Strong intellectual property increases the value of a company. Copyrights, trademarks, patents, and trade secrets are some avenues to protect intellectual property, but understanding when they’re available and understanding...more

Blog: FDA Releases Draft Guidance for Reporting Adverse Events Related to HCT/Ps

The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under...more

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Now's the Time to Comment on the FDA's New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more

EU Issues Guidance to Clarify Transitional Measures for Data Requirements for Plant Protection Products and Active Substances

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FDA Issues Draft Guidance That Affects Health IT

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

93 Results
|
View per page
Page: of 4

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×