Gillian Russell on Draft Guidance

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

7/15/2024 / Advertising , Disclosure Requirements , Draft Guidance , Enforcement , False Advertising , Food and Drug Administration (FDA) , Labeling , Medical Devices , Misleading Statements , Prescription Drugs

FDA Updates Draft Guidance on Promotional Labeling and Advertising Considerations for Biological Reference Products and...

On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar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

4/26/2024 / Advertising , Biosimilars , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Labeling

Beyond Reprints for Scientific Information on Unapproved Uses of Medical Products

Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more

10/27/2023 / Comment Period , Digital Platforms , Draft Guidance , Food and Drug Administration (FDA) , Medical Supplies , Off-Label Promotion , Off-Label Use

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

7/3/2023 / Advertising , Direct to Consumer Sales , Draft Guidance , Final Guidance , Food and Drug Administration (FDA) , Labeling , Prescription Drugs

FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products

Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more

2/10/2020 / Anti-Competitive , Biologics , Biosimilars , Clinical Trials , Comment Period , Draft Guidance , False Advertising , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Labeling , Misleading Statements , Prescription Drugs , Public Comment

FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

1/26/2017 / Draft Guidance , First Amendment , Food and Drug Administration (FDA) , Off-Label Promotion , Pharmaceutical Industry , Public Comment

FDA Issues Draft Guidance Addressing Communications with Payors

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

1/23/2017 / 21st Century Cures Act , Draft Guidance , FDAMA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , HCEI , Investigational New Drug Application (IND) , Manufacturers , Material Dissemination , Payor Contracts , Safe Harbors , Section 502

Gillian Russell

King & Spalding

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