The Office of Pharmaceutical Science (OPS)
is an integral part of CDER's new and generic drug product
application review process. The goal of OPS is to help
establish common approaches to the manufacture and formulation of
drugs among pharmaceutical manufacturers. OPS contributes to
assuring the quality of drug products by providing uniform policies
and review processes for the entire pharmaceutical industry.
OPS coordinates its activities with its
sister office, the Office of New Drugs (OND). The
Office of Pharmaceutical Science was created in a 1995 CDER
reorganization and has about 500 of CDER's 1,700 employees.
OPS has four main offices:
- Office of Generic Drugs
- Office of New Drug Chemistry
- Office of Clinical Pharmacology and
Biopharmaceutics
- Office of Testing and Research
Staff working in these offices have
backgrounds in chemistry, biopharmaceutics, clinical pharmacology,
pharmaceutical science, microbiology, pharmacology/toxicology and
labeling.
Activities
of OPS include:
- Supporting the review function within the
Center for Drug Evaluation and Research (CDER).
- Promoting the adherence to and
development of sound regulatory policy and
decision-making.
- Managing discipline-related Coordinating
Committees.
- Managing the Advisory Committee for
Pharmaceutical Science.
- Managing the information technology
infrastructure and initiatives that support the review
process.
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OPS facilitates the linking of laboratory research to regulatory
practice by working closely with CDER Coordinating Committees.
OPS gives the Coordinating Committees research findings to assist in
the Committees' review of important regulatory issues. These
committees develop new guidances and regulations, and implement
initiatives from the International
Conference on Harmonisation (ICH).
OPS provides scientific and
regulatory support by:
- Developing and implementing review management and
scientific policies pertaining to the new drug review
process for chemistry, manufacturing controls, clinical
pharmacology and biopharmaceutics.
- Evaluating and approving abbreviated new drug
application (ANDAs) and their amendments.
- Developing and implementing policies and programs
through applied regulatory research working with groups
inside and outside FDA.
- Performing drug testing and scientific evaluation of
drug products in support of the regulatory components of
FDA.
- Developing and implementing standards and policies for
both generic drugs and new drugs that enhance the drug
development and regulatory review process.
- Providing scientific oversight, through the Center's
Office of New Drug Chemistry, of chemistry and
manufacturing controls (CMC) and the sterility sections of
Investigational New Drugs, New Drug Applications, and
supplements.
- Validating the comparability of clinical safety and
efficacy studies conducted during the IND phase of drug
development, and evaluating the impact of drug-to-drug
interactions and population characteristics on the safety
and efficacy of drug products.
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The OPS organization chart
shows the divisions within each Office.
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- Advisory
Committee for Pharmaceutical Science (ACPS) .
The ACPS provides the Agency with an objective sounding
board for scientific questions, emerging issues,
prospective guidances, and general criteria for evaluation
in chemistry and human biopharmaceutic review that are not
related to a specific products. ACPS also provides
the means for critical review of intramural and extramural
research.
- OPS
Coordinating Committees . These committees
establish policies and procedures for CDER to ensure high
quality scientific reviews and promote consistency.
They also promote and coordinate discipline-specific
workshops, professional development, and internal
research.
- Process
Analytical Technologies (PAT) web page
(Posted 2/5/2003)
- International
Harmonization Activities. OPS participates in
the International
Conference on Harmonization (ICH) along with the
European Union and Japan. The goals are: (1) to
harmonize the interpretation and application of technical
guidelines and requirements, and (2) to reduce or
eliminate duplicate testing during research and
development in participating countries.
- Publications
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Regulatory
Information
How
to Contact Us
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web site. What information is and isn't useful to you?
Are there any additional items or categories of information
you would like us to add? Please e-mail David
Holovac, holovacd@cder.fda.gov
with feedback about this site.
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