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:2/28/2017)... ... ... ACEA Biosciences, a pioneer in cell analysis instrumentation and the development of ... as the new Vice President of Global Clinical Development. With more than 15 ... will now team with Dr. Li Xu, Chief Medical Officer, and Dr. Xiao Xu, ...
(Date:2/28/2017)... ... February 28, 2017 , ... ... science and biotechnology companies today announced it named Joan Siefert Rose as ... out of Durham, NC and will begin work immediately. , Rose most recently ...
(Date:2/28/2017)... , Feb. 28, 2017 Sangamo ... genome editing, today reported its fourth quarter and ... "Early this year we rebranded our ... clinical development of genomic therapies using our industry ... gene regulation and cell therapy," said Sandy ...
(Date:2/27/2017)... 2017 A Europe-wide survey of institutes conducted ... animals in their research treat them with due care. The survey ... analysis of the results indicates that there is a strong commitment ... into practice the principles of the 3Rs (Refine, Reduce, Replace)  ... What are the ...
Breaking Biology Technology:
(Date:2/3/2017)... A new independent identity strategy consultancy firm ... . Designed to fill a critical niche in technical ... partners Mark Crego and Janice Kephart ... identity expertise that span federal governments, the 9/11 Commission, ... combined expertise has a common theme born from a ...
(Date:1/31/2017)... , Jan. 31, 2017  Spero Therapeutics, ... therapies for the treatment of bacterial infections, today ... of antibacterial candidates from Pro Bono Bio Ltd ... prevalence of multi-drug resistant forms of Gram-negative bacteria.  ... Anti Infectives Ltd, a PBB group company. ...
(Date:1/24/2017)... Jan. 24, 2017 Biopharm Reports has ... laboratory use of nuclear magnetic resonance spectroscopy (NMR). ... and profiled current practices, developments, trends and end-user ... as growth and opportunities. These areas include growth ... instruments, needs and innovation requirements, hyphenated NMR techniques, ...
Breaking Biology News(10 mins):