Drug and Device Regulatory Approvals
The path to FDA approval of a drug or device is a long and winding process with differing nuances and complexities in each of the various approval systems. There are several avenues for FDA approval depending on whether the product is a drug or device. Additionally, there are different application processes for new drugs and generics of a branded drug. Navigating the stringent and detailed requirements of the applications while developing the required data for submission is often a long and difficult process.
Prior to the commencement of formal clinical trials in the development of a new drug, the FDA requires notification to the FDA through an Investigational New Drug Application (INDA). Amongst other requirements, the IND requires applicants to provide details of proposed manufacturing controls and clinical trial protocol. If the FDA does not object to the IND within 30 days the clinical trial may commence, however, the FDA may invoke a “clinical hold” if the FDA believes there is a problem in the contents of the IND. In the event that the applicant successfully submits an IND application and successfully conducts clinical trials, the applicant will also need to submit a New Drug Application (NDA) for FDA regulatory approval.
Generic drug applicants must prepare and submit an Abbreviated New Drug Application (ANDA) to the FDA for regulatory approval. In order for a drug to be ANDA-eligible the drug’s active ingredients must have already received FDA approval for the drug’s intended use (i.e., the FDA approved the active ingredients for the intended use in a branded drug’s NDA) and there is no reason to call into question the original approval of the branded drug’s NDA. The primary requirement for regulatory approval, amongst several requirements, is that the generic drug is “bioequivalent” to the branded drug.
A device manufacturer is required to submit a 510(k) notification to the FDA prior to: 1) the initial distribution of a new device in the market, 2) a modification or change to a cleared device that may significantly affect the safety or efficacy of the device, and 3) a major modification or change to the intended use of a cleared device. In all three instances the 510(k) process involves a comparison of the device to a legally marketed device. The 510(k) enables the FDA to determine whether the new device is equivalent to a device already placed in one of the three existing device classification categories. The 510(k) application must demonstrate that the device meets a standard of “substantial equivalence” to an approved and classified device, meaning that the device is as safe and effective as a legally marketed device. The 510(k) applicant may not market the device until the applicant receives an “order” from the FDA stating that the device meets the “substantially equivalent” standard.
KLS knows that each application to the FDA for any form of regulatory approval must be prepared and submitted with detailed precision in order to successfully receive regulatory approval. KLS’ industry experts understand the challenges and nuances surrounding each drug and device application requirements and the standards for successful submission. KLS will work directly with your team to assist and counsel throughout the entire application process. KLS’ expertise will aid your team in the navigation of the complexities and challenges of the application process to achieve successful regulatory approval.