21 U.S.C. § 360bbb–1 — Dispute resolution

Sometimes the FDA and a drug or device sponsor, applicant, or manufacturer disagree about the science behind a legal requirement under this Act or under section 351 of the Public Health Service Act. This section covers what happens when no existing law or regulation — including a regulation issued under that Act — already gives that person a way to get the disagreement reviewed. In that situation, the Secretary must write a regulation setting up a review procedure. The sponsor, applicant, or manufacturer can use it to ask for a review of the scientific controversy. That review can include a look by a scientific advisory panel, described in section 355(n), or an advisory committee, described in section 360e(g)(2)(B). Any review requested under this procedure must happen in a timely manner. The Secretary had to issue the regulations creating this procedure within one year of November 21, 1997.