The FDA has recently issued a number of new draft guidance documents that provide insight on a range of issues, including expedited drug review programs, medical device reporting, importation of unapproved drugs for market launch, and safety labeling changes. A brief summary and link to each draft guidance document is provided below:

  • Expedited Programs for Serious Conditions: Drugs and Biologics – This draft guidance provides a single resource for information on policies and procedures related to FDA’s expedited drug development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review. The draft guidance is intended to help industry better understand each program, including when the programs can be used and the features of each.
  • Medical Device Reporting for Manufacturers – This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. The document provides answers to frequently asked questions and includes a section on common reporting errors.
  • Pre-launch Activities Importation Request – This draft guidance describes FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for market launch, based on anticipated approval of a pending application (e.g., NDA, ANDA, BLA). It also describes the procedures for making such requests and the factors that FDA will consider in granting such requests.
  • Safety Labeling Changes: Implementation of Section 505(o)(4) of the FD&C Act– Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, which was added by section 901 of the Food and Drug Administration Amendments Act of 2007, authorizes FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product. This draft guidance explains how FDA intends to implement section 505(o)(4), including a description of the types of safety labeling changes that ordinarily might be required under this section, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.