Elevating Investigational New Drug (IND) applications: A guide to well-crafted submissions
Introduction: Navigating the IND Application Landscape
An Investigational New Drug (IND) Application is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
IND application requires the development of high-quality documents by collating all nonclinical, clinical, and scientific data in a standard, thorough and logical manner for the Agency's review. The role of medical writers in creating well-crafted submissions for regulatory approval role is crucial
Decode: Making use of the Guidance and Consultation Programs
Pre-IND Consultation Program
Early communications between sponsors and new drug review divisions aim to provide guidance on the data necessary to warrant IND submission.
Guidance Documents of IND
These documents provide FDA review staff and applicants/sponsors with guidelines for the processing, content, and evaluation/approval of applications and also for the design, production, manufacturing, and testing of regulated products.
Laws, Regulations, Policies, and Procedures
The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. The law is intended to assure that drugs and devices are safe and effective for their intended uses and that all labelling and packaging are truthful, informative, and not deceptive.
Code of Federal Regulations (CFR)
Section 21 of the CFR contains most regulations pertaining to food and drugs. The regulations document all actions of all drug sponsors that are required under Federal law.
Articulating Accordingly: Preclinical Data Compilation
INDs are early submission documents; hence, they focus on preclinical evidence for safety and pharmacological activity. These need to include the justification for the chosen nonclinical program and the adequacy of the safety precautions set in the clinical protocol. The writing perspective of preclinical modules in INDs differs from the Marketing Approvals as preclinical data in the latter is discussed in the context of clinical data available.
Crafting Critical Chemistry Manufacturing Control (CMC) Information-Effectively
This section requires information regarding drug product composition, manufacturing, stability, and control. It should also have information to support an adequate and consistent supply of the study drug.
Scientific data interpretation is an essential component of CMC compilation. It requires skilled and experienced people with relevant backgrounds who can understand and interpret the scientific data, have the know-how of the regulatory requirements, and have the knowledge to identify gaps.
Articulating Clinical Trial Designs: Protocol Narration
This section requires detailed protocols for proposed clinical studies to assess whether the initial phase trials will expose subjects to unnecessary risks along with information on clinical investigators and commitment to obtain informed consent from research subjects. Clarity and precision is key here.
Role of Medical Writers in Crafting Excellent IND Submissions
IND documents are lengthy and complex documents which require accurate presentation of scientific information. Medical writers have good scientific knowledge along with good writing skills which can help in the seamless submission of these crucial documents.
The regulatory team at Bham Pharma has experience in writing INDs.
Get in touch and we can work together to support your business needs.
Medical Writer II & Medical Devices Lead