Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications -
On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
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This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more
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The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more
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On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more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Draft Guidance ,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
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
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers.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Draft Guidance ,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