Navigation Links
It's in the mail -- Responding to an FDA warning letter

Wisconsin companies regularly and eagerly await responses from the FDA to requests for authorization of clinical trials involving investigational products, submissions for premarket clearance of medical devices, and other submissions and applications. But a different type of FDA letter -- a warning letter -- is much less welcome.

Warning letters provide wri......

Full article >>> event report is not a warning letter.

A warning letter can come from one of the FDA's district offices, such as the Minneapolis District, or one of its product-based centers, such as the Center for Drug Evaluation and Research.

Warning letters generally are sent to the highest known official in an organization (e.g., president or CEO). Warning letters usually require a response w......

Full article >>> as specific as possible, and explain what actions the company has taken and plans to take, it is important to follow these steps if a warning letter arrives:

Review the warning letter very carefully. Evaluate the specific violation or violations alleged, and what action is demanded.
If the letter seems unclear, contact the listed FDA contact person for clarification.
A careful......

Full article >>> h the agency, but also leave the company particularly vulnerable to an FDA enforcement action.

Patricia Kaeding, an attorney, was an associate chief counsel at the FDA in Rockville, Md from 1993 to 2003. FDA & Your Business appears monthly on WTN.
The opinions expressed herein or statements made in the above column are solely those of the author and do ......

Full article >>>
'"/>

Source:wistechnology.com By Patricia Kaeding 08/12/05


Related biology technology :

1. SC Johnson issues trademark warning over web offer
2. Company issues warning on outsourced software
3. Report card praises Wisconsin economy, but comes with warning
4. Madison company urges disaster warning upgrades
5. Wisconsin gets "biotech hotspot" designation from industry newsletter
6. Ten red flags in your Midwest technology offer letter
7. DEMOletters Summer Reading List
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:4/19/2017)... , ... April 18, 2017 , ... ... Halo Labs . The move comes after the company changed focus to making ... our new brand and our new technology,” says CEO Robert Hart. Founders Bernardo ...
(Date:4/19/2017)... ... April 19, 2017 , ... ... makes educational webinars accessible to novices as well as experienced users, attendees will ... commonly performed coagulation screening tests. , Hemostasis testing quality is determined by ...
(Date:4/19/2017)... FRANCISCO, Calif. , April 19, 2017 /PRNewswire/ ... VCYT ) today announced that it will report ... of market on Wednesday, May 3, 2017. Following the ... webcast at 4:30 p.m. Eastern Time to discuss the company,s ... live webcast and subsequent replay may be accessed ...
(Date:4/18/2017)... ... , ... For a historic seventh consecutive year, Benchmark Research along with PMG ... one of the top two Clinical Research Sites or Network. Benchmark Research ... four times previously, and first runner up the other three years. The only awards ...
Breaking Biology Technology:
(Date:3/9/2017)... , March 9, 2017 4Dx has ... World Lung Imaging Workshop at the University of Pennsylvania. ... invited to deliver the latest data to world leaders ... event brings together leaders at the forefront of the ... lung imaging. "The quality of the ...
(Date:3/7/2017)... BRIGHTON, England , March 7, 2017 Brandwatch ... been chosen by The Prince,s Trust to uncover insights ... insights across The Trust. The UK,s leading youth charity ... track social campaign results and get a better understanding of the ... ...
(Date:3/6/2017)... 2017 Mintigo , the leader ... Predictive Sales Coach TM , its new artificial ... into Salesforce. This unique AI application will allow ... with deep knowledge of their customers and prospects ... Predictive Sales Coach extends Mintigo,s existing customer success ...
Breaking Biology News(10 mins):