United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2003_register
executive
2010-09-23
article
Guidance for Industry on Continuous Marketing Applications: Pilot 1-Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Act of 1992
Notices
D09002ee1bdeb795d
D09002ee1bdeb79cc
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
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 1--Reviewable Units for 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). Pilot 1 will enable certain applicants to receive early feedback on portions of their applications. Pilot 1 will also evaluate the benefits and costs of providing early feedback to applicants.
68 FR 57697
https://www.govinfo.gov/app/details/FR-2003-10-06/03-25306
03-25306
fr06oc03-66
4160-01-S
Docket No. 2003D-0228
https://www.govinfo.gov/app/details/FR-2003-10-06/03-25306
https://www.govinfo.gov/content/pkg/FR-2003-10-06/html/03-25306.htm
https://www.govinfo.gov/content/pkg/FR-2003-10-06/pdf/03-25306.pdf
2 p.
57697
57698
68 FR 57697
Guidance for Industry on Continuous Marketing Applications: Pilot 1-Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Act of 1992; Federal Register Vol. 68, Issue
NOTICE
03-25306
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2003D-0228
4160-01-S
03-25306
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Continuous Marketing Applications: Pilot 1--Reviewable Units for 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). Pilot 1 will enable certain applicants to receive early feedback on portions of their applications. Pilot 1 will also evaluate the benefits and costs of providing early feedback to applicants.
Submit written or electronic comments on agency guidances at any time.
John Jenkins, CDER (HFD-020), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301- 594-3937, or
Reports and guidance documents; availability, etc.:
Continuous marketing applications
Pilot 1; fast track products under Prescription Drug User Fee Act of 1992; reviewable units,
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
continuing
daily
deposited
born digital
191 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2003-10-06
P0b002ee1809ad02e
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr06oc03
https://www.govinfo.gov/app/details/FR-2003-10-06
https://www.govinfo.gov/content/pkg/FR-2003-10-06/pdf/FR-2003-10-06.pdf
https://www.govinfo.gov/content/pkg/FR-2003-10-06/xml/FR-2003-10-06.xml
fdlp
57607
57782
DGPO
2010-09-23
2023-05-04
FR-2003-10-06
machine generated
eng
FR
FR-2003-10-06
68
193