FDA Notifies Pharmaceutical Companies that Studies
Conducted by Cetero Research May Require Reevaluation
The FDA is notifying pharmaceutical
companies that bioanalytical studies
conducted by Cetero Research, Houston,
Texas (Cetero) between April 2005 and
June 2010 in support of marketing
applications may need to be repeated or
confirmed. Cetero is a contract research
organization (CRO) that performs
bioequivalence and pharmacokinetic
testing for a number of pharmaceutical
companies.
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How can PharmaSys help?
FDA Cetero Research Questions and Answers
What actions has FDA taken?
Why did FDA issue this letter to Cetero?
What were the findings in the inspections of Cetero?
Why was Cetero’s response to the findings inadequate?
What is FDA asking Cetero to do? What impact does this
action have on pending applications and drugs already
approved? What is FDA asking of sponsors of ANDAs and NDAs?
Is there a risk to the public? Should patients stop taking
their medications?
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How can PharmaSys help?
Cetero Research Responds to FDA Untitled Letter
Cary, NC (July 27, 2011) Cetero Research, the leading provider
of early phase research services, remains fully committed to maintaining
the quality and integrity of the data collected in each of its facilities,
including the Houston, TX, bioanalytical laboratory.
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I'm a Sponsor
with work Performed at Cetero. What should I do?
You should immediately contact the FDA to discuss potential
next steps which may include repeat testing, reanalysis of samples,
or providing a justification as to why neither retesting
nor reanalysis are necessary for FDA to review or approve your application.
To provide justification as to why neither retesting nor reanalysis are
necessary, you should hire a reputible auditing service with direct
experience with these types of situations to
conduct a 100% inspection of your bioanalytical records.
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How can PharmaSys help?
How can PharmaSys help?
PharmaSys has performed over 50 audits of bioanalytical studies
in response to an FDA notification similar to the recent FDA
notification directing drug sponsors who had studies performed
at Cetero Research between April 2005 and June 2010 in support of
marketing applications may need to confirm that the results are
valid or repeated the studies.
All of PharmaSys’ previous audit reports were submitted to the FDA
and/or the EMA and resulted in acceptance of the marketing applications.
(Some of the studies did require corrective actions and/or reanalysis of data)
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