Investigational New Drug Applications - Overview
For conducting clinical trials across the United States (US) with an Investigational New Drug or drugs that are not approved for intended use, the sponsor must submit an Investigational New Drug Application (IND) to the US FDA which is known as IND Filing and obtain FDA’s 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 Applications to assure product quality, safety, and scientific evidence on the proposed efficacy profile during the IND approval process, 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 / IND Approval process with the US FDA include:
- Identification of Regulatory requirements for the intended FDA IND Submission (e.g., Phase I, Phase II, Phase III).
- Ensuring GMP/GLP compliance throughout the IND approval process.
- 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 the 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 throughout the IND approval process, starting from pre-IND meetings to Regulatory compliance and management of FDA IND submissions in an efficient manner until IND becomes effective.
Investigational New Drug Applications - Expertise
- Strategic support in IND filing in identifying the optimal Regulatory approach for an intended clinical program(s) and FDA 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 drug 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 of 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.).
- FDA 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 re-activation and IND Approval Process.
- US agent services for IND filing.
