Rapid Response Fact Sheet
The Rapid Response Team (RRT) was created in
November of 2000, as part of the reengineering of the Office of Testing and
Research (OTR). The RRT is a composed of
a group of multidisciplinary scientists from the Office of Pharmaceutical
Sciences, including OTR, ONDC, OCPB and OGD.
The group is directly under the Office of Pharmaceutical Sciences
(OPS). The primary function of the RRT
is to provide timely and specific research support (laboratory-based or
literature-based) for designated regulatory issues that require further agency
study. The RRT responds to well-defined
scientific questions that are raised by CDER review divisions. The goal is to
provide the review divisions with sound scientific data, or literature, which
will be used in the regulatory process.
The projects that are accepted by the RRT are expected to have a short
turnaround time, because they are given high priority and are considered to be
PDUFA activities. Following the
completion of a Rapid Response Project, a report is written and made available
to the review division. The RRT reports
are expected to serve as consults to the review division.
Accomplishments:
The following is a list of some of the
projects that the RRT has completed to date:
1.
Determination of the bioequivalence of
generic versions of cyclosporin versus the innovator product. Response time 4 months.
2.
Dissolution properties of levothyroxine
tablets. Response time 2 weeks.
3.
Providing OGD with information on
Imipramine biopharmaceutical classification standards. Response time 2 months.
4.
Providing information on whether a
chemical or assay or a bioassay for Urofollitropin needed to be conducted by
the sponsor, determination of bioequivalence.
Response time 3 weeks.
5.
Doxycycline Hyclate tablet palatability
study in human subjects, to identify dosing regimens that would be appropriate
for pediatric populations in the event of a bioterrorism incident. Response time 3 weeks.
6.
Potassium Iodide tablet palatability
study in human subjects, to identify dosing regimens that would be appropriate
for pediatric populations in the event of a bioterrorism incident. Response time 2 months.
7.
Permeability study of commercially
available gloves to lindane lotion and shampoo
Ongoing
projects:
1.
Assessing the neurotoxicity of ketamine
in juvenile animals in order to extrapolate to pediatric populations currently
dosed with ketamine for setting of broken bones. This project is ongoing and has been
nominated to the NTP (National Toxicology Program) for further evaluation in
primates.
2.
Ciprofloxacin tablet palatability and
bioequivalence study in human subjects.
3.
Neurotoxicity of Accutane in a rodent
model.
4.
BCS classification, dissolution and
potency of commercially available levothyroxine drug products.
Not all the completed or currently ongoing
projects have been described in the list above.
In-House
capabilities:
|
Division |
Expertise |
Lab. Equipment |
|
Laboratory of Clinical Pharmacology
(LCP, Mod 1 and NLRC) |
·
Analysis of drugs in biological
fluids ·
Use of human liver tissue for
pharmacological studies in vitro ·
Application of Pharmacokinetics to
metabolism and drug-drug interactions ·
Assessment of reactive metabolites
as potential hepatotoxins ·
Characterization of imaging targets
as biomarkers |
HPLC (several detectors), LC-MS-MS, GC,
GC-MS, Radiochemical detectors
|
|
Division of Pharmaceutical Analysis (DPA, |
·
Characterization of Reference Standards ·
Evaluation and Validation of Regulatory Analytical Methods ·
Analytical Method Development ·
Forensic and Counterfeit Evaluation ·
Compliance Investigations |
GC (FID, TC, EC, Flame Photometric,
MS detectors), HPLC (MS, MS/MS, Fluorescence, UV/VIS, RI, PDA, IC detectors),
Capillary Electrophoresis, TLC, IR, NIR, UV/VIS, Thermal (TGA/DSC),
Titrators, Dissolution apparatus, Particle sizing. In addition, personnel are on staff with
experience in NMR, Raman, Fluorescence and Chemometrics. |
|
Division of Product Quality Research (DPQR) |
·
In Vitro Drug Permeability ·
Analytical Method Development ·
·
Shelf Life Stability Studies ·
Dissolution ·
Botanicals |
Stability Chambers, GC, HPLC, Dissolution apparatus,
Capillary Electrophoresis, HPLC (UV, |
|
Division of Applied Pharmacology Research (DAPR) |
·
Whole Animal Studies ·
Molecular Biology (PCR, DNA Sequencing, Oligonucleotide
Synthesis, Gel Electrophoresis, Gene Typing/Gene Expression analysis, Image
analysis ·
Biochemistry (Enzyme assay, Western blotting) ·
Clinical chemistry and Immunology (ELISA, Flow cytometry,
cell culture) ·
Biomarker identification ·
Cytogenetics |
Animal facility, High Throughput Sequence detection
system, Oligonucleotide DNA Synthesizer, Electrophoresis, Cameras, darkroom
facilities and imaging software, Flow Cytometer, cell sorter, Cell culture
equipment, Zeiss Photomicroscope, |
Available
funds:
Funds for appropriate research projects are
made available by OPS.
Standard
format for RRT proposals:
The following information needs to be
available to RRT prior to initiation of a project:
1.
Title of project
2.
Introduction/Relevance to FDA and
public health impact
3.
Questions that the study will address
4.
Expectations from the Rapid Response
Team
5.
Anticipated regulatory outcome (how
will be information generated be used)
6.
Expected time frame for completion of
the project
Process
for requesting RRT involvement:
The formal process is as follows:
1.
The sponsor of a project provides RRT
member with information to complete the above listed format. This will constitute a Draft proposal. All potential projects, whether accepted by
RRT or not deemed appropriate, need to have a Draft Proposal submitted to RRT.
2.
The draft proposal is discussed at the
RRT meeting for review.
3.
The RRT decides on the appropriateness
of the draft proposal and responds to the sponsor of the proposal in a timely
manner.
4.
The RRT will collaborate with the
sponsor to write a detailed proposal that will serve as the basis for the study
design
5.
The RRT will carry out the study
6.
The RRT will write the report and
submit it to the sponsor
Rapid
Response Members:
Nakissa Sadrieh, Chair (OPS) [sadriehn@cder.fda.gov]
Lucinda Buhse (OTR)
Eric Duffy (ONDC)
Joseph Hanig (OTR)
Shiew Mei Huang (OCPB)
Ajaz Hussain (OPS)
Robbe Lyon (OTR)
Moheb Nasr (OTR)
Solomon Sobel (OPS)
John Strong (OTR)
Donna Volpe (OTR)