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:11/30/2016)... and BEIJING , Nov. ... leading commercial provider of genomic services and solutions with ... today that it has completed a USD $75 Million ... Bank Co., Ltd.,s CMB International Capital Management ( ... Investment Management Co., Ltd. ("SDIC Innovation") and Shanghai Sigma ...
(Date:11/30/2016)... November 30, 2016 Part of 5m$ ... ... Aptuit, LLC today announced that it had successfully ... 150,000 novel compounds have increased the Screening Collection to over ... hit discovery capabilities of the company. This expansion, complemented by ...
(Date:11/30/2016)... (PRWEB) , ... November 30, 2016 , ... SSCI, the ... to discuss the implications of the latest FDA guidance on pharmaceutical cocrystals as ... 2016 in Cambridge, MA. , The event follows the successful November 15th ...
(Date:11/30/2016)... ... November 30, 2016 , ... T3D Therapeutics, Inc., a clinical ... treatment for Alzheimer’s disease (AD), today announced that CEO, John Didsbury, will be ... T3D-959 in mild to moderate Alzheimer’s patients at CTAD 2016. Preliminary results of ...
Breaking Biology Technology:
(Date:6/27/2016)... 27, 2016 Research and Markets has announced ... report to their offering. ... to grow at a CAGR of 12.28% during the ... on an in-depth market analysis with inputs from industry experts. The ... coming years. The report also includes a discussion of the key ...
(Date:6/20/2016)... June 20, 2016 Securus Technologies, a ... solutions for public safety, investigation, corrections and monitoring ... involved, it has secured the final acceptance by ... for Managed Access Systems (MAS) installed. Furthermore, Securus ... to be installed by October, 2016. MAS distinguishes ...
(Date:6/7/2016)... -- Syngrafii Inc. and San Antonio Credit Union (SACU) ... Syngrafii,s patented LongPen™ eSignature "Wet" solution into SACU,s ... in greater convenience for SACU members and operational ... document workflow and compliance requirements. Logo ... Highlights: ...
Breaking Biology News(10 mins):