FDA Advice for Regulatory Submissions

This blog reviews the importance of planning and communication with the FDA related to firms’ regulatory submissions. For the past two days, I was fortunate enough to attend a training seminar hosted by the FDA in Washington, DC. This was a “free” seminar (i.e., – travel expenses only). The session was split into two rooms. One room focused on drug regulations, and the other focused on device regulations. As my strength is a device, I spent most of my time listening to the speakers on the drug-side. Throughout the training, there was one common theme that was repeated by the speakers: Come Early, Be Loud, and Stay Late.

“Come Early”

The speakers recommend that companies plan their submissions well in advance and talk to the appropriate FDA project manager about their plans before starting clinical studies.

“Be Loud”

The speakers recommend that companies communicate with as many people as they can at FDA to ensure they have identified all the critical issues to address in the study design.

“Stay Late”

The speakers recommend that companies think ahead so that if (or when) things don’t go as planned, the clinical study results can be salvaged. In simple and more practical terms, every speaker emphasized the importance and value of consulting with the FDA, instead of guessing what type of data will be needed for submission. One of the other participants brought this up at lunch on the first day. He mentioned an example where the FDA agreed with a company on specific data that would be required for acceptance of an NDA. The company did exactly what the FDA said, and then the FDA requested more data. He later described another case where the FDA specified data, and the company refused to comply—but the FDA granted approval. This other participant and I both agreed that most companies are afraid to ask the FDA for agreement on what data is required because the company may not like the FDA’s answer.

My personal belief is that the FDA is better at identifying what data will be required than most companies because they have a broader perspective than companies do. There will always be exceptions, but my recommendation is to ask FDA’s opinion whenever you have a question—just ensure you do your homework before you ask an inane question that is already in their guidance documents. I believe this advice also applies to every regulatory agency in the world.