New drug development plays a vital role in the lives of human beings. For instance, they help treat and prevent new diseases through vaccination. Additionally, they help in the treatment of previously untreatable conditions, the development of cost-effective drugs, etc.
However, one of the obstacles to developing new drugs is the approval process needed before the drugs can be utilized. The Food Drug and Administration (FDA) approval indicates that the Center for Drug Evaluation and Research (CDER) has examined a drug regarding its efficacy and side effects before legally entering the market.
This process follows a firmly established structure to ensure that only efficient and secure drugs are approved; hence, taking a long time. Thankfully, some strategies can help you speed up this process. Read on for details:
1. Understand The clinical Trial Submission Standards
Various standards are required for data submission to FDA, and among them is the Analysis Data Model (ADaM). Understanding the ADaM standards is crucial as it enables you to create analysis datasets and linked metadata. This lets you quickly produce listings, figures, and tables, ensuring traceability. This, in turn, enables reviewers to evaluate and approve your submission swiftly.   Â
2. Apply For Accelerated Approval Method
The FDA uses two approval methods for medications: traditional and accelerated procedures. The traditional approval method is one of the most widely used for most medications. In this pathway, a clinical endpoint is used to determine the clinically meaningful benefit of a drug before it’s approved. Clinical endpoints evaluate the results of a medical intervention to direct clinical decision-making. They assess how well a drug can help cure or prevent symptoms of a particular disease. However, this period may take long before the FDA approves your medication.
On the other hand, accelerated drug approval doesn’t use a clinical endpoint. Instead, it utilizes a surrogate endpoint. A surrogate endpoint is a label such as a radiographic image or laboratory measurement thought to forecast clinical benefit, but it isn’t a standard for clinical benefit. FDA uses an accelerated approval method for medications for adverse conditions that meet an unmet medical need. Unmet medical needs are conditions without good prevention, diagnosis, or treatment methods.
Utilizing surrogate endpoints saves significant time during the drug approval process. For instance, rather than waiting to know if a medication can prolong the survival period for cancer patients, FDA may approve a medicine according to the proof that it shrinks tumors.
3. Request For Fast Track Designation
Fast track is a procedure intended to help create and accelerate medication approval to cure severe illnesses and fill unmet medical needs. The goal is to obtain vital new drugs for patients earlier. For your application for a fast track to be accepted, you must prove that your medication will influence factors like survival, daily operation, or the possibility that the situation, if left untreated, will advance to a more severe condition.
In case therapies are available, a fast-track medication must demonstrate some benefits over existing treatments, including the following:
- Preventing adverse side effects of existing therapy
- Ability to handle expected public health demands
- Displaying outstanding efficiency, impact on significant results, or enhanced effect on effective outcomes
- Enhancing the diagnosis of a difficult situation where the previous diagnosis leads to an improved outcome
By receiving fast track designation, you can achieve the following benefits:
- More regular written communication from the FDA regarding factors like the design of the suggested clinical trials and the utilization of biomarkers
- Qualification for accelerated approval if you meet the appropriate criteria
- Regular meetings with the FDA to examine the medicine’s development strategy and ensure the collection of relevant data required to aid drug approval
You may request fast-track designation at any time during the production process and allow the FDA to determine early whether your medication fills an unmet need in an adverse situation. Once you receive the designation, frequent communication with the FDA ensures you promptly resolve any questions and issues, leading to early drug approval.
4. Apply For Priority Review
Unlike the standard review designation, which takes approximately 10 months, a priority review takes around six months. Applying for this designation helps reduce the drug approval process. Ideally, priority review focuses attention and resources to the assessment of medications that, if approved, would significantly improve particular conditions. The improvement can be:
- Proof of safety and efficiency in a new subset
- Removal or significant decrease of a treatment-confining medical reaction
- Proof of enhanced efficiency in the diagnosis, prevention, or cure of a disease
Priority review is part of the FDA review process but requesting it in advance and expediting the drug approval process is advisable.
Conclusion
Speeding up the drug approval process enhances patients’ access to treatment for severe, untreatable, or life-threatening diseases. Therefore, make sure you understand and follow the clinical trial submission standards and apply for the various designations. Additionally, your drug fills the unmet medical demands for FDA to approve your medication and eventually save lives quickly.
