News & Analysis as of

Draft Guidance

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

by McDermott Will & Emery on

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

FDA Issues Draft Guidances to Scale Back Regulation of Digital Health Software

by Ropes & Gray LLP on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued two draft guidance documents that describe types of software functions that FDA will not regulate, including FDA’s long-awaited policy on clinical...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

by Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

Food and Beverage News and Trends

by DLA Piper on

FDA issues draft guidance on the creation of GRAS panels. The FDA has issued draft guidance on the best practices for a manufacturer to follow when convening a panel of experts to evaluate whether a substance is “generally...more

UK Tax Round Up - November 2017

by Proskauer Rose LLP on

UK Tax News and Developments - The OTS publishes its report "Value added tax: routes to simplification" - On 7 November, the Office of Tax Simplification (OTS) published its first report on VAT, which included a range...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

by Hogan Lovells on

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 7

by Jones Day on

USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more

FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants

by McDermott Will & Emery on

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

The Article 29 Working Party Releases Draft Guidelines on the Application and Setting of Administrative Fines

by WilmerHale on

One of the key components of the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”) is its stronger enforcement mechanisms. Administrative fines are one of the most powerful parts of the enforcement...more

FDA Draft Guidance on Menu Labeling

by Foley & Lardner LLP on

On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

FDA Withdraws Draft Guidance For Industry #230

by Reed Smith on

The U.S. Food & Drug Administration (“FDA”) announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.”...more

Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, "Menu Labeling: Supplemental Guidance for Industry" (Draft Guidance). In the Draft Guidance, FDA addresses comments it received...more

Draft FY 2018 – 2022 EPA Strategic Plan: October 31st Association of Air Pollution Control Agencies Comments

The Association of Air Pollution Control Agencies (“AAPCA”) submitted October 31st comments on the United States Environmental Protection Agency’s (“EPA”) Draft FY 2018 – 2022 Strategic Plan (“Plan”). EPA states the Plan...more

FDA Sets the Stage for Cures Act Breakthrough Devices Program in Highly Anticipated Guidance Document

by Reed Smith on

On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway...more

Key GDPR Guidance on Behavioral Advertising, Profiling and Automated Decision-Making

Spoiler Alert: Behavioral advertising companies will find some bad news in the guidance. The Article 29 Working Party (WP29) advisory group, which will soon become the more transparently-named (and very powerful) European...more

The Article 29 Working Party Releases Draft Guidelines on Breach Notification

by WilmerHale on

On October 18, the Article 29 Working Party released its draft of “Guidelines on Personal data breach notification under Regulation 2016/679” (“Guidelines on Personal data breach notification,” WP250). The guidelines are not...more

The Article 29 Working Party releases draft guidelines on profiling and automated decision-making under the GDPR

by WilmerHale on

On October 18, the Article 29 Working Party released its draft of “ Guidelines on Automated individual decision-making and Profiling for the Purpose of Regulation 2016/679” (“Guidelines on Automated individual decision-making...more

EPA Extends Comment Period for Draft Guidance for Pesticide Registrants on Notifications, Non-notifications and Minor Formulation...

by Bergeson & Campbell, P.C. on

On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications...more

FDA Draft Guidance Describes FDA’s Current Thinking on Evaluating Analytical Similarity for Biosimilar Products

by Goodwin on

Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes the type[s] of...more

European Central Bank Releases Guide on Assessment of Fintech Bank License Applications

by Morgan Lewis on

Earlier this month, the European Central Bank (ECB) released a draft guide to provide a consistent approach on how to assess fintech credit institution license applications. The guide defines fintech banks as having “a...more

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Cybersecurity

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