News & Analysis as of

Draft Guidance Public Comment

Troutman Pepper

EPA’s New Proposed Maui Guidance: Underwhelming and Sneaky

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On November 20, with no fanfare at all, not even a press release, U.S. Environmental Protection Agency (EPA) issued its Draft Guidance: Applying the Supreme Court’s County of Maui v. Hawaii Wildlife Fund Decision in the Clean...more

Holland & Knight LLP

EPA Issues Guidance on Maui Factors

Holland & Knight LLP on

The U.S. Environmental Protection Agency (EPA) announced release of its Draft Guidance Regarding NPDES Permitting of Certain Discharges through Groundwater to Surface Waters (Draft Guidance) on Nov. 20, 2023, notice of which...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

BakerHostetler

State Attorneys General Take a Strong Pro-Enforcement Stance in Comments to Draft Merger Guidelines

BakerHostetler on

On Sept. 18, 2023, 19 Democratic state attorneys general (AGs) filed public comments to the Draft Merger Guidelines (Draft Guidelines) proposed by the U.S. Department of Justice and the Federal Trade Commission (the Agencies)...more

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

Foley Hoag LLP on

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Knobbe Martens

FDA Releases Draft Guidances on 510(k) Submissions

Knobbe Martens on

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more

Goodwin

Antitrust & Competition Technology Quarterly Update - Q2 2023

Goodwin on

Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more

King & Spalding

FTC and DOJ Announce New Draft Merger Guidelines

King & Spalding on

vOn July 19, 2023, the U.S. antitrust enforcers, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) (collectively, the “Agencies”), released draft merger guidelines for public...more

Troutman Pepper

The Evolution of the FTC and DOJ Continues: Agencies Seek Public Comment on Draft Merger Guidelines

Troutman Pepper on

The Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) jointly issued new draft Merger Guidelines on July 19. The draft Merger Guidelines were created with the goal "to better reflect how the agencies...more

K&L Gates LLP

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Foster Garvey PC

FDA Issues Draft Guidance on Naming and Voluntary Nutrient Statements for Plant-Based Milk Alternatives

Foster Garvey PC on

On February 23, 2023, the Food and Drug Administration (FDA) announced the issuance of a draft guidance document entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry.”...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more

Orrick, Herrington & Sutcliffe LLP

Japan Renewables Alert 61

On November 8, 2022, the draft of the “guidelines for public tender of exclusive occupancy and use” (the “Public Tender Guidelines” and the draft of the Public Tender Guidelines for Round 2, the “Draft Guidelines”) for “Round...more

Cooley LLP

FDA Unveils Considerations for Rescinding Breakthrough Therapy Designation

Cooley LLP on

On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation. The guidance explains how the FDA may rescind a drug or biologic...more

Goodwin

Safety First! Much-Anticipated FDA Draft Guidance Provides Additional Advice on the Development of Human Genome Editing Products

Goodwin on

Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more

Hogan Lovells

FDA invites comment on guidance on meetings with OTC sponsors

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more

Goodwin

Planning for the End: FDA Issues Draft Guidance for Transitioning EUA and Enforcement Policy Medical Devices Marketed During the...

Goodwin on

During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of...more

Hogan Lovells

(Solo self-employed) Workers of the World Unite! – EC draft guidance on application of competition law to collective bargaining

Hogan Lovells on

The European Commission has published draft Guidelines on the application of competition law to collective bargaining involving the working conditions of the “solo self-employed”. The draft Guidelines clarify the Commission’s...more

Hogan Lovells

FDA transition plan for COVID-19 medical devices requests new submissions to agency

Hogan Lovells on

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more

White & Case LLP

JFTC and METI Proposes Guidelines for Business Collaboration with Startups and Investment in Startups

White & Case LLP on

On December 23, 2021, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") proposed a draft of Guidelines for Business Collaboration with Startups and Investment in Startups...more

Goodwin

On Remote Control: FDA Issues Draft Guidance to Facilitate Use of Digital Health Technologies for Remote Data Acquisition in...

Goodwin on

During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more

Goodwin

Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data and Real-World Evidence to Support...

Goodwin on

Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence (RWE) for...more

Goodwin

It’s Starting to Register: FDA Draft Guidance Addresses Use of Registries to Support Regulatory Decision-Making for Drugs &...

Goodwin on

Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a registry or use an existing registry to...more

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