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Perkins Coie

OFCCP Releases New AI Guidance for Federal Contractors

Perkins Coie on

The Office of Federal Contract Compliance Programs (OFCCP) released updated guidance for the use of artificial intelligence (AI) by federal contractors on April 29, 2024—the latest indication that federal contractors’ use and...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Morgan Lewis

FSIS Advises on Animal-Raising Label Claims but Issues Still Exist

Morgan Lewis on

The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims...more

Hogan Lovells

FSIS Issues Updated Labeling Guideline on Statements That Bioengineered or Genetically Modified Ingredient or Animal Feed Were Not...

Hogan Lovells on

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued an updated Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not...more

Hogan Lovells

DDTC Publishes FAQs on U.S. Persons Working Abroad & ITAR Defense Services

Hogan Lovells on

On 6 January, 2020 DDTC announced guidance regarding U.S. persons providing defense services while abroad. ...more

Hogan Lovells

FSIS Issues Revised Compliance Guidelines for Animal Raising Claims

Hogan Lovells on

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a revised compliance guideline for substantiating animal raising claims on labels for meat and poultry products. This updated...more

Ballard Spahr LLP

Banking Regulators Ease SAR Reporting Requirements Applied to Hemp-Related Businesses

Ballard Spahr LLP on

On December 3, 2019, four federal agencies – the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation (“FDIC”), the Financial Crimes Enforcement Network (“FinCEN”), and the Office of the...more

Lowndes

Long-Awaited Guidance for Banking Hemp Clients Released

Lowndes on

Since the effective date of the 2018 Farm Bill, banking and the inability to acquire financing have been major impediments for the hemp industry. While demand for hemp continues to grow, banking regulations have still been...more

Mintz - Privacy & Cybersecurity Viewpoints

Revised Guidelines on the Territorial Scope of the GDPR and Local Representatives

The European Data Protection Board (EDPB) recently published an updated version of its guidelines on the territorial scope of the GDPR, which were initially issued just over a year ago. The revised Guidelines do not...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

McNees Wallace & Nurick LLC

EEOC Will Cease Collecting EEO-1 Component 2 Pay Data

The Equal Employment Opportunity Commission (EEOC) announced on September 11, 2019 that it will not be seeking renewal for collection of EEO-1 Component 2 pay data, which requires employers with 100 or more employees to...more

Littler

EEOC Provides Guidance on EEO-1 Filing for Non-Binary Employees

Littler on

The Equal Employment Opportunity Commission (EEOC) recently released guidance in an FAQ to employers as to how they should report non-binary employees on Form EEO-1....more

Hogan Lovells

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

Hogan Lovells on

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

Hogan Lovells

New French Guidelines on Cookies and Trackers

Hogan Lovells on

On 19 July the French Data Protection Authority (the “CNIL”) published new guidelines on cookies and trackers. These replace the existing Recommendation No. 2013-378 of 5 December 2013, are intended to be in line with...more

Hogan Lovells

NIH issues long-awaited guidance on other support, foreign components, and financial conflicts of interest

Hogan Lovells on

On 10 July 2019 the National Institutes of Health (NIH) issued its long-awaited guidance addressing grantee disclosure obligations related to researchers' activities outside the United States. ...more

Polsinelli

New Guidelines on GDPR’s Territorial Scope

Polsinelli on

The European Data Protection Board (“EDPB”) recently released Guidelines 3/2018 on the territorial scope of the GDPR (Article 3). ...more

Hogan Lovells

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Hogan Lovells on

The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric...more

Hogan Lovells

FDA Issues Two Guidance Documents on New Nutrition Labeling Requirements

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

Polsinelli on

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

Hogan Lovells

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

Hogan Lovells on

The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more

Bricker Graydon LLP

FDA issues guidance on use of EHR data in clinical research

Bricker Graydon LLP on

Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

Seyfarth Shaw LLP

OSHA Releases Two New Temporary Worker Guidance Documents

Seyfarth Shaw LLP on

OSHA has just reminded temporary staffing agencies and their clients (i.e., host employers) that they are jointly responsible for a temporary employee’s safety and health in two new guidance documents relating to respiratory...more

Hogan Lovells

FSIS Issues Guidance on Retailer and Restaurant Exemptions from Inspection Under the Federal Meat Inspection Act

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) recently released a guidance document to help companies determine whether their operations are exempt from the inspection requirements of...more

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