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FDA Updates Draft Guidance on Promotional Labeling and Advertising Considerations for Biological Reference Products and Biosimilars | King & Spalding

On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and...
King Spalding Promotional Labeling Advertising Considerations Prescription Biological Reference Products Biosimilar Products Interchangeable Biosimilar Products

FDA Issues Revised Draft Guidance on "Off-Label" Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain | Dechert LLP

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about โ€œoff-labelโ€ uses of approved products. The Revised Draft Guidance...
Categories Of Communications Communications Should Not Use Persuasive Marketing Techniques Device Manufacturer Communications With Payors Drug Administration Communications Should Be Clinically Relevant Revised Draft Guidance

Key NEPA-GHG Issues For The Biden-Harris Administration: Focus On FERC Chairman Glick And Incoming CEQ Chair Mallory - Environment

To print this article, all you need is to be registered or login on Mondaq.com. In the coming weeks, the Council on Environmental Quality (CEQ) will reveal its plan for revising the National Environmental Policy Act (NEPA) regulations and guidance for analyzing greenhouse gas (GHG) emissions. Indeed, this will be one of the highest priority items for incoming CEQ Chair, Brenda Mallory, who was just confirmed by the Senate in a 53 to 45 vote on April 14, 2021. In the mean...
United States Mountain Valley Ethan Shenkman Brenda Mallory Energy Regulatory Commission Dominion Transmission Inc
Source: mondaq.com

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