- FDA Finalizes Two Guidance Documents Concerning Sunscreen TEAs
- November 2, 2016 | Authors: Jonathan Berman; Colleen M. Heisey; Francoise S. Labrousse; Katherine M. Llewellyn; Cristiana Spontoni
- Law Firms: Jones Day - Washington Office ; Jones Day - Paris Office ; Jones Day - Brussels Office
On October 11, 2016, pursuant to the deadline set out in the Sunscreen Innovation Act ("SIA"), FDA finalized two of the four guidance documents published in draft form on November 23, 2015. These guidance documents relate to the time and extent application ("TEA") process to request a new over-the-counter ("OTC") drug monograph for sunscreens or to amend an existing monograph to recognize that a sunscreen active ingredient or condition is generally recognized as safe and effective ("GRASE"). The final versions of these two guidance documents, titled "Withdrawal of a 586A Request or Pending Request" and "Section 586C(c) Advisory Committee Process," are almost identical to the draft guidance documents. FDA received only two comments for each of them, all of which were rejected by the agency.
The first guidance addresses the expected effect of a withdrawal on key phases of the SIA process, including withdrawals made prior to or after the initial eligibility determination, the submission of safety and efficacy data, the filing determination, or the GRASE determination. This guidance also discusses the submission of a new 586A request for the same sunscreen ingredient for which a 586A or pending request had been previously submitted and withdrawn.
The second guidance provides background information on the OTC sunscreen monograph process, as well as on the Agency's intended process for convening the Nonprescription Drugs Advisory Committee ("NDAC"). It also recommends procedures for sponsors of 586A requests and for sponsors of pending requests to follow in requesting an NDAC meeting. This guidance also explains how FDA intends to process these requests and describes the factors the agency may consider in determining whether and when to refer such requests to the NDAC.