Description
This document provides guidance to industry and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on good review management principles and practices (GRMPs) for the conduct of the first cycle review of a new drug application (NDA), a biologics license application (BLA), or an efficacy supplement under the Prescription Drug User Fee Act of 1992 (PDUFA). The GRMPs in this guidance are based on the collective experience of CDER and CBER with review of applications for PDUFA products and are intended to promote the practice of good review management based on sound fundamental values and principles. This guidance also clarifies the roles and responsibilities of review staff in managing the review process and identifies ways in which NDA and BLA applicants may further the effectiveness and efficiency of the review process.
Scope & Applicability
Product Classes
3review and approval process for new drugs
A situation requiring additional pediatric safety data collection.
Products for which batch/lot information is particularly important
Stakeholders
7entity submitting marketing applications
Convened to provide advice on withdrawal issues
The submitter will be contacted by the RPM who will provide a BQ number; Regulatory Project Manager provided as a contact.
Responsible for conducting review and completing primary review
FDA personnel managing the review process; FDA personnel performing application reviews
FDA staff member involved in informal interactions
Person responsible for making the decision on the official regulatory action; Brief signatory authority during review phase; Responsibility for wrap-up meeting and action package review
Regulatory Context
Attributes
2Specific performance goals FDA agreed to meet
Designation for applications that provide significant improvements
Related CFR Sections (10)
- 21CFR314.103§ 314.103 Dispute resolution.
(a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated applications as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →
- 21CFR314.102§ 314.102 Communications between FDA and applicants.
(a) General principles. During the course of reviewing an application or an abbreviated application, FDA shall communicate with applicants about scientific, medical, and procedural issues that arise during the review process. Such communication may take the form of telephone conversations, letters, Read full regulation →
- 21CFR601.4§ 601.4 Issuance and denial of license.
(a) A biologics license shall be issued upon a determination by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research that the establishment(s) and the product meet the applicable requirements established in this chapter. A biologics liceRead full regulation →
- 21CFR314.120§ 314.120 [Reserved]
- 21CFR314.110§ 314.110 Complete response letter to the applicant.
(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in § 314.125 or § 314.127 , respectively.Read full regulation →
- 21CFR314.105§ 314.105 Approval of an NDA and an ANDA.
(a) FDA will approve an NDA and send the applicant an approval letter if none of the reasons in § 314.125 for refusing to approve the NDA applies. FDA will issue a tentative approval letter if an NDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but caRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR54.5§ 54.5 Agency evaluation of financial interests.
(a) Evaluation of disclosure statement. FDA will evaluate the information disclosed under § 54.4(a)(2) about each covered clinical study in an application to determine the impact of any disclosed financial interests on the reliability of the study. FDA may consider both the size and nature of a discRead full regulation →
See Also (8)
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)
- Special Protocol Assessment Guidance for Industry (Status: Final)
- Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (Status: Draft)
- Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry (Status: Final)
- Requests for Reconsideration at the Division Level Under GDUFA (Status: Final)