Tips to get your assay approved by the FDA

April 1, 2019







  1. Always tell the truth.
  2. Don’t offer information that wasn’t asked for. As an example,
    FDA: Your study is acceptable.
    You: We have another study that also confirms that.
    FDA: Oh, tell me about it… Result is a 6 week delay.
  3. Don’t speculate. As an example,
    FDA: What caused that outlier?
    You: We think it might be an interfering substance.
    FDA: Oh, Let’s review your interference studies…
  4. Know when to say yes and when to say no.
    Agree to change wording, graphs, and so on. Also agree to change calculation methods even when you think your original methods are correct. Challenge a finding that requires you to repeat or provide new studies, unless you agree.
  5. Don’t submit data that doesn’t meet specifications. Doesn’t sound smart but I’ve seen it happen.