Description
This guideline is intended to assist drug firms in preparing the summary to a new drug application required under 21 CFR 314.50(c).
Scope & Applicability
Product Classes
3RTRT and CTD sections apply to drug products
General drug development considerations for this class apply
The term final dosage form means, with respect to a prescription drug product...
Stakeholders
4Convened to provide advice on withdrawal issues
facilitate discussions between a prospective subject and an investigator; Responsible for conducting research and providing informed consent
Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting NDINs
Regulatory Context
Attributes
7A functional role of sodium in food
The applicant should formulate a brief benefit/risk assessment of the drug.
data pertinent to drug-drug interactions
Required description for maternal and offspring findings
Proportionality of absorption over the therapeutic range
established based on data from stability studies
expressed as a numerical value or range
Related CFR Sections (4)
- 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 →
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
- 21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
See Also (8)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
- Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (Status: Final)
- Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives (Status: Final)
- Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (Status: Final)
- Format and Content of the Microbiology Section of an Application*: Guidance for Industry (Status: Final)
- Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (Status: Final)