FDA consultants, like Biotech Research Group, can provide support and regulatory submissions for FDA fast track service. FDA Fast Track is a way to speed up the supply of drugs for unmet medical needs. FDA introduced this approach for “providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.” Formally requesting a Fast Track designation could result in enhanced interactions with FDA, such as more frequent meetings and written communications with FDA, Accelerated Approval and Priority Review eligibility, as well as possible Rolling Reviews.
This approach has been offered to provide a quicker mechanism to provide a drug to the specific patient population. There were many successful Fast Track FDA approvals in 2019. These were across many types of health conditions including, but not limited to, cardiac, cancer, antibacterial, neurological and psychiatric disorders, and nutritional defects. A project that could offer a drug via FDA fast track could benefit from expert direction from an FDA consultant.
FDA consultants, such as Biotech Research Group, have worked on a variety of Fast Track projects . Along with the FDA fast track, consultants can explore a number of options that would best fit your drug product. Many FDA consultants also offer medical devices services as well. Sometimes there is overlap between drugs and devices with FDA in combination products. If an FDA consultant is needed for a combination product, be sure to ask if the provider has had experience with combination products as well as drugs and devices alone.
There are regulatory strategies to reach a greater level of success. Each project has its own special needs, so be sure to choose an experienced FDA consultant.