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2010-09-23
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Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992
Notices
D09002ee1bdeb795c
D09002ee1bdeb79cb
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA.'' This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA). This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of development for certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot 2 program.
68 FR 57696
https://www.govinfo.gov/app/details/FR-2003-10-06/03-25305
03-25305
fr06oc03-65
4160-01-S
Docket No. 2003D-0229
https://www.govinfo.gov/app/details/FR-2003-10-06/03-25305
https://www.govinfo.gov/content/pkg/FR-2003-10-06/html/03-25305.htm
https://www.govinfo.gov/content/pkg/FR-2003-10-06/pdf/03-25305.pdf
2 p.
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68 FR 57696
Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Federal Register Vol. 68, Issue
NOTICE
03-25305
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-10-06
Docket No. 2003D-0229
4160-01-S
03-25305
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA.'' This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA). This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of development for certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot 2 program.
Submit written or electronic comments on agency guidances at any time. FDA will begin accepting applications for participation in Pilot 2 on October 6, 2003.
John Jenkins, CDER (HFD-020), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3937, or
Reports and guidance documents; availability, etc.:
Continuous marketing applictions
Pilot 2; fast track products development under Prescription Drug User Fee Act of 1992; scientific feedback and interactions,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 68, no. 193
Office of the Federal Register, National Archives and Records Administration
2003-10-06
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191 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2003-10-06
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https://www.govinfo.gov/content/pkg/FR-2003-10-06/xml/FR-2003-10-06.xml
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