Posts tagged OPDP.
Blogs
less than a minute
by Wendy C. Goldstein and Kathleen A. Peterson
On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.
The FDA has a longstanding policy of permitting ...
Blog Editors
Recent Updates
- The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”
- Eliminating the GRAS Pathway: An Update
- Brand Licensing in Health Care: An Overview for Hospitals
- FDA Proposal Would Extend Food Traceability Rule’s Compliance Deadline to July 2028
- NYDFS Cybersecurity Crackdown: New Requirements Now in Force, and "Covered Entities" Include HMOs, CCRCs—Are You Compliant?