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Safe Harbors Draft Guidance

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

White & Case LLP

European Commission issues proposed guidance on information exchange in dual distribution relationships

White & Case LLP on

As part of its review of the EU antitrust rules governing vertical agreements, the European Commission (EC) has published for consultation a draft new section of its Vertical Guidelines, which contains proposed guidance on...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

Goodwin on

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

King & Spalding

FDA Issues Draft Guidance Addressing Communications with Payors

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On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

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