The review
teams analyze new drug applications (NDAs) and
biologic licensing applications (BLAs). During
drug development, the teams also review
Investigational New Drug Applications (INDs).
Each team member uses their expertise to
answer these key questions:
- Is it
reasonably safe to study an investigational
drug in humans and will proposed studies
provide data needed to show safety and
efficacy?
- Is the drug
safe and effective in its proposed use and
do the benefits of the drug outweigh the
risks?
- Is the
proposed labeling appropriate and if not
what should it contain?
- Are the
methods used in manufacturing the drug and
the controls adequate?
Review teams
consist of these members
-
Project Manager - Project managers
are the primary contact with the sponsor.
They coordinate the activities of the review
team throughout the review process. They:
- prepare the
review plan with the team
- monitor the
status of review activities
- maintain
up-to-date information on milestones
- facilitate
actions to solve problems
- assure that
the review is completed on schedule
-
Medical Officer - Medical officers
review all clinical studies. They:
- evaluate and
advise on protocol design, endpoints, and
analysis for drug approval
- evaluate the
clinical investigators who supply the
clinical data
- review the
clinical investigation
- describe and
analyze each clinical pharmacology study
- describe and
analyze controlled and uncontrolled studies
- review other
relevant safety and efficacy data
-
Pharmacology/Toxicology Specialist -
These team members review all nonclinical
(animal)
studies including:
-
pharmacological action of the drug as
related to its intended clinical use
- potential
toxic effects of the drug as related to
its intended use
-
reproductive and /or fetal effects
-
Statistician - These team members:
- provide
conclusions on safety and efficacy study
data
- study the
protocols
- review the
statistical analysis plan
- compare
conduct of the studies against protocol
and analysis plans
- conduct
analyses of safety and efficacy data
-
Clinical Pharmacology/Biopharmaceutics
- These team members:
- evaluate
pilot and background ADME studies
(adsorption, distribution, metabolism, and
elimination)
-
evaluate
bioavailability and bioequivalence studies
-
evaluate
pharmacokinetic studies
- evaluate in vivo
studies using pharmacological or clinical
endpoints
- evaluate in vitro
(laboratory)
studies that define the release rate of
the drug substance from the dosage form
-
Chemists/Biologists/Microbiologists -
These reviewers evaluate the drug
substance/drug product in these areas:
- components
and composition
-
manufacturing and controls
- batch
formulation and records
- description
of facilities
-
specifications and tests
- stability
profile
-
environmental impact analysis report
The following
groups may also be consulted during the review
process:
For more
information on the new drug application
process, please see
http://www.fda.gov/cder/regulatory/applications/default.htm.