Applications Covered by Section
505(b)(2)
DRAFT GUIDANCE
This guidance document is being distributed for comment purpos only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication of the Federal Register notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions on the content of the draft document contact Virginia Beakes, (301) 594-2041.
毛细管粘度计U. S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
October 1999
Applications Covered by Section
505(b)(2)
DRAFT GUIDANCE
简笔画叶子For additional copies, contact:
Drug Information Branch
Division of Communications Management, HFD-210
Center for Drug Evaluation and Rearch (CDER)
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
v/cder/guidance/index.htm.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
October 1999
Table of Contents
I.WHAT IS THE PURPOSE OF THIS GUIDANCE? (1)
II.WHAT IS A 505(B)(2) APPLICATION? (2)
A.W HAT TYPE OF INFORMATION CAN AN APPLICANT RELY ON? (2)
多段线B.W HAT KIND OF APPLICATION CAN BE SUBMITTED AS A 505(B)(2) APPLICATION? (3)
低音笛III.WHAT ARE SOME EXAMPLES OF 505(B)(2) APPLICATIONS? (4)
IV.WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? (6)
V.WHY DOES IT MATTER IF AN NDA IS A 505(B)(2) APPLICATION? (6)
VI.PATENT AND EXCLUSIVITY PROTECTIONS THAT COULD AFFECT A 505(B)(2) APPLICATION (7)
A.W HAT TYPE OF PATENT AND/OR EXCLUSIVITY PROTECTION IS A 505(B)(2) APPLICATION ELIGIBLE FOR? (7)
B.W HAT COULD DELAY THE APPROVAL OR FILING OF A 505(B)(2) APPLICATION? (7)
VII.WHAT SHOULD BE INCLUDED IN 505(B)(2) APPLICATIONS? (7)
REFERENCES (10)
GLOSSARY (11)
GUIDANCE FOR INDUSTRY1
Applications Covered by Section 505(b)(2)
I.WHAT IS THE PURPOSE OF THIS GUIDANCE?
This guidance identifies the types of applications that are covered by ction 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). A 505(b)(2) application is a new drug application (NDA) described in ction 505(b)(2) of the Act. It is submitted under ction 505(b)(1) of the Act and approved under ction 505(c) of the Act. This guidance also provides further information and amplification regarding FDA's regulations at 21 CFR 314.54.
世界上最老的人Section 505 of the Act describes three types of new drug applications: (1) an application that contains full reports of investigations of safety and effectiveness (ction 505(b)(1)); (2) an application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (ction 505(b)(2)); and (3) an application that contains information to show that the propod product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics, and intended u, among other things, to a previously approved product (ction 505(j)). Note that a supplement to an application is a new drug application.
男动漫Section 505(b)(2) was added to the Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This provision expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant. Sections 505(b)(2) and (j) together replaced FDA's paper NDA policy, which had permitted an applicant to rely on studies published in the scientific literature to demonstrate the safety and effectiveness of duplicates of certain post-1962 pioneer drug products (e 46 FR 27396, May 19, 1981). Enactment of the generic drug approval provision of the Hatch-Waxman Amendments ended the need for approvals of duplicate drugs through the paper NDA process by permitting approval under 505(j) of duplicates of approved drugs (listed 1This guidance has been prepared by the Center for Drug Evaluation and Rearch (CDER) at the Food and Drug Administration. This guidance document reprents the Agency's current thinking on the types of applications that may be submitted pursuant to ction 505(b)(2) of the Act. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be ud if such approach satisfies the requirements of the applicable statute, regulations, or both.
drugs) on the basis of chemistry and bioequivalence data, without the need for evidence from literature of effectiveness and safety. Section 505(b)(2) permits approval of applications other than t
ho for duplicate products and permits reliance for such approvals on literature or on an Agency finding of safety and/or effectiveness for an approved drug product.丽江到香格里拉
Definitions for specific terms ud throughout this guidance are given in the Glossary.
II.WHAT IS A 505(B)(2) APPLICATION?
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A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or u from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
A.What type of information can an applicant rely on?
What type of information can an applicant rely on in an application that is bad upon studies
“not conducted by or for the applicant and for which the applicant has not obtained a right of
reference?”
1.Published literature
An applicant should submit a 505(b)(2) application if approval of an application will rely
to any extent on published literature (a literature-bad 505(b)(2)). If the applicant
has not obtained a right of reference to the raw data underlying the published study or
studies, the application is a 505(b)(2) application; if the applicant obtains a right of
reference to the raw data, the application may be a full NDA (i.e., one submitted under
ction 505(b)(1)). An NDA will be a 505(b)(2) application if any of the specific
information necessary for approval is obtained from literature or from another source to
which the applicant does not have a right of reference, even if the applicant also
conducted clinical studies to support approval. Note, however, that this does not mean
any reference to published general information (e.g., about dia etiology, support for
particular endpoints, methods of analysis) or to general knowledge caus the
application to be a 505(b)(2) application. Rather, reference should be to specific
information (clinical trials, animal studies) necessary to the approval of the application.
2.The Agency’s finding of safety and effectiveness for an approved drug
An applicant should submit a 505(b)(2) application for a change in a drug when
approval of the application relies on the Agency's previous finding of safety and/or
effectiveness for a drug. This mechanism, which is embodied in a regulation at 21 CFR
314.54, esntially makes the Agency's conclusions that would support the approval of
