Investigational New Drug Applications - Overview
For conducting clinical trials with investigational drugs or drugs not approved for the intended use, the sponsor must submit an Investigational New Drug Application (INDA) to the United States Food and Drug Administration (US FDA) and obtain the Agency’s acceptance. Post the Investigational New Drug (IND) Application’s approval, the drug is transported or distributed across the US for use in clinical programs. What if the sponsor fails to submit adequate information in the IND application to assure product quality, safety, and scientific evidence on the proposed efficacy profile? In that case, the US FDA may issue a clinical hold (full clinical hold or partial clinical hold), restricting sponsors to move forward unless the issues are addressed.
Freyr assists sponsors with end-to-end Regulatory support in IND programs, from pre-IND meetings to Regulatory compliance and management of late-phase submissions when the IND goes effective.
Investigational New Drug Applications - Expertise
- Gap analysis of IND drug development data against the current Regulatory requirements for conducting human clinical trials and identifying potential clinical hold issues (Critical & Major).
- Request for Orphan Drug Designation (ODD) or expedited review program designations.
- Expert advice on Regulatory mitigation plans for identified data deficiencies and clinical hold issues during the IND approval process.
- Publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.).
- Consulting support for IND inactivation or IND re-activation.
- Preparation, technical reviews, and submission of CMC, nonclinical & clinical packages for initial IND submission, IND amendments, safety reporting, and IND annual reports submission in the eCTD format for different types of medicinal products (new chemical entities, vaccines, biosimilars, and other biological products like tissue and gene therapy products, etc.).
- Regulatory support for pre-IND meetings and other Agency communications (Type A, Type B, Type C, and Biosimilar Biological Product Development (BPD) meetings).
- Strategic support in identifying the optimal Regulatory approach for an intended clinical program(s) and IND submission.
- Extensive understanding of NDA/BLA submission requirements and data correlations, from the IND to future Marketing Authorization Applications (MAAs).
- Regulatory response strategy, preparation, and timely response submission to the US FDA queries/information requests.
- US agent services.
- Investigational New Drug Application submission templates in eCTD format.
