In conjunction with the June 2002
reauthorization of the Prescription Drugs User
Fee Act of 1992 (PDUFA), the FDA agreed to
meet specific performance goals (PDUFA
goals). The PDUFA goals are described in
PDUFA Reauthorization Performance Goals and
Procedures, an enclosure to a letter dated
June 4, 2002, from the Secretary of Health and
Human Services to Congress. The PDUFA goals
can be found at
http://www.fda.gov/oc/pdufa/PDUFAIIIGoals.html.
The PDUFA goals outline the basic elements of
two pilot programs to explore the CMA concept,
Pilot 1 and Pilot 2. These pilot programs are
being coadminstered by CDER and CBER.
CMA Program Specifics:
Both CMA Pilot 1 and CMA Pilot 2 apply only to
certain new drug or biological products that
have been designated as Fast Track products
pursuant to Section 112 of the Food and Drug
Administration Modernization Act of 1997
(Section 506 of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. 356) and that meet
other specified criteria. Both pilots will
operate October 6, 2003, through September 30,
2007, and will include an evaluations
component to determine the added value and
costs of the program and its impact on the
efficiency of the review process.
Applications that meet the relevant acceptance
criteria may be included in both Pilot 1 and
Pilot 2. An application included in the
Pilots also may be subject to other special
development or approval programs (e.g., 21 CFR
314 Subpart H).
CMA
Pilot 1
provides for the review of a limited number of
presubmitted portions of an applicant’s
marketing application (reviewable units)
based on the terms and conditions agreed upon
by the applicant and the FDA. The FDA
guidance document, Continuous Marketing
Applications: Pilot 1 – Reviewable Units for
Fast Track Products Under PDUFA, is
available to explain the details of Pilot 1
design and procedures. The guidance can be
found at:
www.fda.gov/cder/guidance/5739-fnl.pdf
(PDF)
www.fda.gov/cder/guidance/5739-fnl.doc
(Word)
CMA Pilot 2 is
the subject of a separate FDA guidance
document, Continuous Marketing
Applications: Pilot 2 – Scientific Feedback
and Interactions During Development of Fast
Track Products Under PDUFA. The guidance
can be found at:
www.fda.gov/cder/guidance/5740-fnl.pdf
(PDF)
www.fda.gov/cder/guidance/5740-fnl.doc
(Word)
Under CMA Pilot 2, the FDA and applicants can
enter into agreements to engage in frequent
scientific feedback and interactions during
the IND phase of product development. Pilot 2
will include a maximum of one product per
review division.
As of March 9, 2004, the following
Divisions (marked by an X and listed by
Office), have accepted Pilot 2 products and
are therefore not accepting additional
applications for product enrollment into Pilot
2. Remaining Divisions may receive
applications for Pilot 2 enrollment through
September 30, 2004, pending acceptance of an
application (see FDA guidance document for
details).
ODE I |
|
HFD-110
Division of Cardio-Renal Drug Products |
X |
HFD-120
Division of Neuropharmacological Drug
Products |
X |
HFD-150
Division of Oncology Drug Products |
X |
ODE II |
|
HFD-510
Division of Metabolic and Endocrine Drug
Products |
|
HFD-570
Division of Pulmonary Drug Products |
X |
HFD-170
Division of Anesthetic, Critical Care and
Addiction Drug Products |
|
ODE III |
|
HFD-180
Division of Gastrointestinal and
Coagulation Drug Products |
X |
HFD-580
Division of Reproductive and Urologic Drug
Products |
|
HFD-160
Division of Medical Imaging and
Radiopharmaceutical Drug Products |
|
ODE IV |
|
HFD-520
Division of Anti-Infective Drug Products |
X |
HFD-530
Division of Anti-Viral Drug Products |
|
HFD-590
Division of Special Pathogen and
Immunologic Drug Products |
|
ODE V |
|
HFD-550
Division of Anti-Inflammatory Analgesic
and Ophthalmic Drug Products |
X |
HFD-540
Division of Dermatologic and Dental Drug
Products |
|
HFD-560
Division of Over-the-Counter Drug Products |
not
enrolling |
ODE VI |
|
HFM-576
Division of Therapeutic Biological
Internal Medicine Drug Products |
X |
HFM-573
Division of Therapeutic Biological
Oncology Drug Products |
X |
HFM-585
Division of Review Management and Policy |
not
enrolling |