Shionogi direct mailers misleading, FDA says
Pharma Compliance Alert, November 26, 2008
Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers) for Cedax omit and minimize risks associated with the product, according to an FDA warning letter.
The direct mailers are misleading because they present numerous efficacy claims for Cedax but fail to reveal material risk information associated with use of the drug, and suggest Cedax is effective in a broader range of conditions than has been demonstrated by substantial evidence or substantial clinical experience.
Comments
0 comments on “Shionogi direct mailers misleading, FDA says ”
Related Products
-
ePharm5 InDepth
EPharm5 e-mail newsletter delivers the top 5 developments in pharma business innovation, with original research, interviews...
-
Healthcare Marketing Advisor
Healthcare Marketing Advisor provides concise, time-saving strategies for branding, promoting, and advertising your...
-
Marketing Oncology: Strategies for Service Line Campaigns
During this 90-minute Webcast, expert healthcare marketers discuss the research and strategic planning that should be the...
-
The Complete Guide to Hospital Marketing, Second Edition
The Complete Guide to Hospital Marketing, Second Edition looks at the complex field of healthcare marketing in a...
-
Complete Guide to Lab Safety, 3rd Ed.
The third edition of this popular resource makes training and compliance easier by consolidating regulations from all...
Most Popular
- Articles
-
- HIPAA Q&A: Flu shot requirement for hospital employees
- Running an effective peer review committee meeting
- HealthDataInsights posts new issues for medical necessity claims
- Sneak Peek: Effort underway to establish caseload benchmarks
- New FAQ posted on storing laryngoscope blades
- Q/A: Coding for telescopic intraocular lens
- Tip: Perform your own internal investigation prior to government audit
- HIPAA 5010 deadline extended, but threat remains, says AMA
- HHS task force: Consider privacy, security with text messages
- What does case-mix index mean to you?
- E-mailed
-
- Running an effective peer review committee meeting
- HIPAA Q&A: Flu shot requirement for hospital employees
- What does case-mix index mean to you?
- HHS task force: Consider privacy, security with text messages
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Q/A: Coding for telescopic intraocular lens
- Q/A: Correct use of modifier -PT
- Tip: Correctly code bilateral pain management procedures
- "Wall fountains" may be spreading Legionnaires to patients, visitors
- 2012 CPT code changes for ASCs: Shoulder and knee scopes and pain management
- Searched