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)... ... 28, 2017 , ... LaunchBio, a California nonprofit organization that ... it named Joan Siefert Rose as CEO. Rose, a nationally recognized leader ... begin work immediately. , Rose most recently served as the president and CEO ...
(Date:2/28/2017)... MELBOURNE, Australia , Feb. 28, 2017 /PRNewswire/ ... medical technology company, supplier and strategic partner that ... and empowers individual health management, formally announces its ... The name change is part of the ... by the launch of an integrated corporate website, ...
(Date:2/28/2017)... , Feb. 28, 2017 Sangamo Therapeutics, ... editing, today reported its fourth quarter and full ... "Early this year we rebranded our company ... development of genomic therapies using our industry leading ... regulation and cell therapy," said Sandy Macrae ...
(Date:2/28/2017)... The Biotech industry is today,s focus ... equities: ZIOPHARM Oncology Inc. (NASDAQ: ZIOP ), Aurinia ... (NASDAQ: ARNA ), and Marinus Pharmaceuticals Inc. (NASDAQ: ... sector, which was narrowly mixed on Monday, February 27 th ... than 0.1%, while shares of health care companies in the ...
Breaking Biology Technology:
(Date:2/14/2017)... N.C. , Feb. 14, 2017  Wake Forest ... M.D., as its new chief executive officer (CEO). Freischlag ... CEO John D. McConnell , M.D., who last ... position at the Medical Center, after leading it since ... the full scope of Wake Forest Baptist,s academic health ...
(Date:2/8/2017)... NEW YORK , Feb. 8, 2017 /PRNewswire/ ... an individual,s voice to match it against a ... voice such as pitch, cadence, and tone are ... systems require minimal hardware installation, as most PCs ... remotely for different transactions. Voice recognition biometrics are ...
(Date:2/7/2017)... 7, 2017   MedNet Solutions , an innovative ... of clinical research, is pleased to announce that the ... innovative, highly flexible and award winning eClinical solution, is ... iMedNet is a proven Software-as-a-Service (SaaS) clinical research ... (EDC), but also delivers an entire suite of eClinical ...
Breaking Biology News(10 mins):