In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -
On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
6/21/2018
/ Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Required Communications ,
Safe Harbors
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers.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Draft Guidance ,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
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
Program Has Broad Reach -
On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more