Biotech Values

[DewDiligence]

JAV Re: FDA policy on post hoc data corrections

If the data are good and were mismanaged, then the FDA should accept it, IMO.

As a matter of policy, the FDA does not accept post hoc data corrections in an applicant’s favor. Accepting such data would bias the regulatory process in favor of applicants in general insofar as post hoc corrections that worked against a given applicant would presumably not be submitted.

In other words, the FDA’s refusal to accept post hoc data corrections might seem arbitrary and insensitive, but it’s perfectly sound mathematically.