News & Analysis as of

Draft Guidance

EU Trade Update

• European Commission publishes survey on concept of “Specially Designed for Military Use,” and issues request for input for possible EU commercial policy measures targeting the United States • Netherlands introduces...more

Corps of Engineers to Streamline Section 408 Permitting Process

by Holland & Hart LLP on

In February 2018, the U.S. Army Corps of Engineers (“Corps”) issued a draft Engineering Circular (“EC”) outlining proposed policies and procedures regarding how it will address third-party requests to alter civil works...more

European Banking Authority Seeks Feedback on Draft Guidelines on Managing Non-Performing Exposures

by Shearman & Sterling LLP on

The European Banking Authority has commenced a consultation on draft Guidelines on the management of non-performing and forborne exposures. The Capital Requirements Directive requires in-scope banks and investment firms to...more

EU Publishes Draft Guidelines for Future Relationship with Britain

The guidelines present a stark contrast to Prime Minister May’s vision of a “deep and special” partnership with the EU after Brexit. The President of the European Council has issued negotiating guidelines for the future...more

FDA Releases Draft Guidances to Enhance Drug Supply Chain Security

by White and Williams LLP on

On March 1, 2018, the U.S. Food and Drug Administration (FDA) issued two new draft guidances which further the FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). The DSCSA amended the Federal Food, Drug, and...more

Urgent, Urgent, Urgent … Emergency: FDA Advises Companies to Issue Appropriate Product Recall Warnings

by Arnall Golden Gregory LLP on

Channeling the rock band Foreigner and its 1981 hit, “Urgent” (or the Beatles’ “Get Back” single), the Food and Drug Administration issued a draft guidance in January 2018, cautioning industry to properly warn the public...more

FDA Issues Draft Guidance for Obtaining Qualified Infectious Disease Product Designation Under the GAIN Act

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on obtaining "Qualified Infectious Disease Product" (QIDP) designation for antibacterial and antifungal drug candidates intended to treat serious or...more

EPA Guidance Documents Are Not Enforceable Rules Says DOJ

by Miles & Stockbridge P.C. on

Companies regulated by the Environmental Protection Agency (EPA) have long complained that EPA too often uses guidance documents improperly, both to expand regulatory requirements beyond what the law permits and to avoid...more

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

Draft 408 Guidance imminent; USACE Webinars Scheduled

by Downey Brand LLP on

Happy New Year!!!!!! Yes, it is actually February, but it is a new year for this blog as we turn our attention to a world full of flood risk reduction actions in the second year of the Trump Administration. We are hearing...more

FDA Issues Draft Guidance for "Least Burdensome” Approach to Device Regulation

by Knobbe Martens on

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance...more

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

by Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

by McDermott Will & Emery on

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims...more

FDA Update: Agency Seeks to Strengthen Public Warning and Notification of Recalls, Exercises FSMA Enforcement

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things: Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical...more

ESMA Publishes Consultation Paper Containing Draft Guidelines on Anti-Procyclicality Margin Measures for Central Counterparties...

On January 8, 2018, the European Securities and Markets Authority (“ESMA“) published a consultation paper containing draft guidelines on anti-procyclicality margin measures for central counterparties (“CCPs“)...more

FDA to step up enforcement of homeopathic medicine

by Thompson Coburn LLP on

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

New FDA Guidance Clarifies Exemptions for Digital Health Software

• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Year in Review: Top Five Legal Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

by Latham & Watkins LLP on

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

FDA Issues Draft Guidances on Targeted Therapies and the Use of Standards

by Goodwin on

The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions...more

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

by Reed Smith on

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060...more

Consent under the GDPR: Official Guidance Now Available

One of the most striking changes to EU privacy law under the EU’s General Data Protection Regulation (which goes into effect May 25, 2018) is the very strict approach to user consent. For many years, companies operating in...more

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