Center for Drug Evaluation and Research (CDER)
and the Office of Pediatric Therapeutics (OC)
Agency: Food and Drug Administration (FDA), HHS
This notice announces the availability of a scheduled rotation in the FDA available to Pediatric pharmacology fellows in training in good standing in an established academic program The primary goal of the rotation program is to introduce the fellows to regulations related to pediatric drug development and to application of clinical pharmacology and biopharmaceutics principles for regulatory decision making as well as advancing application of clinical pharmacology for dose selection, dosing recommendations and ultimately labeling.
The rotation program is envisioned as a collaborative program where the fellows interact with members of multidisciplinary review teams, pediatrics, pharmacometrics and pharmacogenomics experts in OCP, PMHT, ONDQA,OTS and OPT in FDA. Prior to initiation of the rotation program, an outline of each individual’s project will be developed by the fellow’s supervisor in consultation with the FDA point (s) of contact and may be further refined as the project progresses.
I. Purpose of the Program
- Promote regulatory opportunities for individuals engaged in clinical pediatric pharmacology training and establish formal outreach links to academic training programs.
- Contribute to the professional education and training of clinical pediatricpharmacologists in the United States.
- Expand the presence of clinical pediatric pharmacology within CDER at FDA.
- Provide interaction opportunities for scientific and clinical staff in the Offices with fellows via joint projects and training programs.
II. Logistics of the Program
Fellows must provide evidence of approval from their home institution to attend the FDA for the pediatric pharmacology rotation. Fellows must provide the requested information for security and conflict of interest assessments. Fellows, through their training program director, should contact Eldridge Coles, Senior Management Officer, using the address provided at the end of this announcement for information regarding the rotation program and indicate timeframes, their expectations from the rotation and special interests.
The length of the rotation program is flexible although a minimum of between four and six weeks is preferable.
B. Selection of Candidates
The rotating fellows will be selected by representatives from the participating offices. Eligibility criteria will include:
- A pharmacology fellow in an academic training program, in good standing and who has completed at least 1 year of training.
- A letter of support from the fellowship director.
- CV of the fellow
- Submission of all application materials by the deadline, Sept 10th, 2007 for those applying for rotations in 2008.
The preparation background packages will be provided to the candidate for review prior to the rotation. This package will include pertinent information from Pharmacology and the Pediatric groups. Core examples such as written requests previously submitted and examples of dosing differences found in exclusivity studies will be provided including references.
Funding for the fellow’s expenses will be solely secured and provided by the Fellow’s sponsoring institution.
D. Confidentiality and Publication Policy
- Anyone involved in this rotation must understand and agree to FDA’s requirements concerning confidentiality surrounding information that they will have access to while at the FDA. This will include signing a confidentiality agreement.
- Any proposed publication utilizing information gained during the experience at the FDA must be cleared through the FDA’s usual clearance process prior to publication.
The fellow must indicate a quarterly period when he/she will be available for the rotation and his/her preference for the one month or the two months rotation program.
Those selected must complete an application for a personal background check, and security clearance, and must also sign a confidentiality agreement. In order for the application to be considered for calendar year 2008 all documents must be submitted by Sept. 10th, 2007.
Eldridge Coles, Senior Management Officer
FDA/CDER/OND/Program Management Team
White Oak building 22
10903 New Hampshire Avenue
Silver Spring, MD 20993