Guidance Documents

Draft Guidance for Preparing a Pre-Request for Designation

On February 15, FDA issued a draft guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP)…

Guidance May Not be Used as a Substitute for Rule making

By Sharif AhmedDepartment of Justice

On November 2017, Trump Administration issued a memo stating that “the Administrative Procedure Act requires notice-and-comment rulemaking when purporting to create rights or obligations binding on members of the public or the agency.” In the memo the Department of Justice stated that “The Department will no longer engage in this…

New Draft Guidances on Medical Product Communications

By Sharif AhmedFood and Drug Administration

Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products. The first draft guidance, “Drug and Device Manufacturer Communications with…