News & Analysis as of

Final Rules Draft Guidance

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Goodwin

US Antitrust Agencies Release Final Revised Merger Guidelines

Goodwin on

On December 18, 2023, the Federal Trade Commission (FTC) and the Antitrust Division of the Department of Justice (DOJ) (each an Agency, and collectively, the Agencies) released the final version of revised Merger Guidelines...more

McGuireWoods Consulting

Washington Healthcare Update - November 2021 #2

This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more

King & Spalding

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

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Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

Skadden, Arps, Slate, Meagher & Flom LLP

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Akin Gump Strauss Hauer & Feld LLP

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

McAfee & Taft

Comment period for FDA's draft nutrition, menu labeling guidance ends Nov. 2

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On December 1, 2014, the Food and Drug Administration published its final rule on Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 FR 71156. This rule requires restaurants...more

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