Continuous Marketing Application (CMA) Pilot Programs
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 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.
The CMA concept builds on the current practice of interaction between the FDA and applicants during drug development and application review and proposes improvements. Under PDUFA, Pilot 1 and Pilot 2 will be conducted to allow for a comprehensive assessment of the added value, costs, and impact of more extensive feedback during drug development and early review of parts of marketing applications.
FDA will use this web site to provide information on the design and status of the Continuous Marketing Application (CMA) Pilot Programs.
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 [PDF], is available to explain the details of Pilot 1 design and procedures.
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 [PDF]
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).
Division of Cardio-Renal Drug Products
Division of Neuropharmacological Drug Products
Division of Oncology Drug Products
Division of Metabolic and Endocrine Drug Products
Division of Pulmonary Drug Products
Division of Anesthetic, Critical Care and Addiction Drug Products
Division of Gastrointestinal and Coagulation Drug Products
Division of Reproductive and Urologic Drug Products
Division of Medical Imaging and Radiopharmaceutical Drug Products
Division of Anti-Infective Drug Products
Division of Anti-Viral Drug Products
Division of Special Pathogen and Immunologic Drug Products
Division of Anti-Inflammatory Analgesic and Ophthalmic Drug Products
Division of Dermatologic and Dental Drug Products
Division of Over-the-Counter Drug Products
Division of Therapeutic Biological Internal Medicine Drug Products
Division of Therapeutic Biological Oncology Drug Products
Division of Review Management and Policy