Description
The purpose of this guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach.
Scope & Applicability
Product Classes
5Products produced in microbial cells or cell lines; Complex molecules manufactured in living cells
Circumstance where a mass balance study might not be recommended
proinflammatory cytokines or therapeutic proteins causing cytokine increases
A type of ATMP involving recombinant nucleic acids or viral vectors.
Specific type of therapeutic protein discussed for DDIs; Focus of biologics DDI evaluation.; ADCs consist of a small molecule drug component conjugated to an antibody.
Stakeholders
2Entity responsible for submitting applications under section 524B
Sponsors should consult regarding hybrid or augmented data approaches
Regulatory Context
Attributes
1factor to consider when evaluating DDI potential
Related CFR Sections (2)
- 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 →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
See Also (8)
- Classification Categories for Certain Supplements Under BsUFA III (Status: Final)
- Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (Status: Final)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)
- Useful Written Consumer Medication Information (CMI) (Status: Final)