For conducting clinical trials with investigational drugs or drugs that are not approved for intended use, the sponsor must submit an Investigational New Drug Application (INDA) to the US FDA and obtain Agency acceptance before the drug is transported or distributed across the US for use in the clinical program.
In case the sponsor fails to submit adequate information in the IND Application to assure product quality, safety, and scientific evidence on proposed efficacy profile, the US FDA may issue a Clinical Hold (full clinical hold or partial clinical hold) which restricts sponsors to move forward unless the issues are addressed. Some of the challenges in the IND filing process with the US FDA includes:
- Identification of Regulatory requirements for the intended IND Application (e.g. Phase I, Phase II, Phase III).
- GMP/GLP compliance.
- Product specific scientific knowledge to manage Regulatory issues (e.g. New Chemical Entities, Biologics, Radioactive Labelled Drugs, etc.).
- Managing clinical hold issues and appropriate mitigation plans for potential clinical hold issues.
- Parallel planning of IND filing process and other clinical trial related logistics (e.g. clinical trial sites’ readiness, clinical material manufacturing & testing, cGMP compliance at CMO sites, etc.).
- Managing ongoing CMC changes/protocol changes and being compliant with Regulatory requirements/federal requirements for an active IND (CMC amendments/protocol amendments, safety reporting, annual reporting, etc.).
To ensure compliant IND filing, Freyr assists sponsors with end-to-end Regulatory support for IND programs, starting from pre-IND meetings to Regulatory compliance and management of late phase submissions when the IND goes effective.
- Strategic support in identifying the optimal Regulatory approach for an intended clinical program(s) and IND submission.
- Regulatory support for pre-IND meetings and other agency communications (Type A, Type B, Type C, and Biosimilar Biological Product Development (BPD) meetings).
- Request for ODD (Orphan Drug Designation) or for expedited review program designations.
- Gap-analysis of IND developmental data against the current Federal Regulatory requirements for conducting human clinical trials, and to identify potential clinical hold issues (critical & major).
- Expert advice on Regulatory mitigation plans for the identified data deficiencies and clinical hold issues during the IND process.
- Extensive understanding on NDA/BLA submission requirements and data correlations from IND to facilitate future Marketing Authorization Applications.
- Preparation, technical review, and submission of CMC, non-clinical & 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.).
- IND submission templates in the eCTD format.
- Publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.).
- Regulatory response strategy, preparation, and on-time response submission to the US FDA queries/information requests.
- Consulting support for IND inactivation or IND re-activation.
- US agent services.