U.S. Food and Drug Administration News

In late June 2014, the FDA released a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The guidance announced that these types of systems and devices would no longer need to comply with some of the FDA’s regulatory controls — such as registration and post-market surveillance reporting.

In addition, the FDA issued a draft strategic priorities document for 2014-2018. Released in early July 2014, this document announces that the FDA’s priorities include regulatory science, safety and quality, smart regulation and globalization. According to the draft document, the FDA hopes to make the drug development and review processes more straightforward and transparent.

The FDA has also released several documents for compounded drug products. These include:

  • A draft interim guidance on compliance with current good manufacturing practice (CGMP) requirements for outsourcing facilities
  • Two Federal Register Notices that the nomination process is being reopened for active pharmaceutical ingredients (APIs) that can be used to compound drug products
  • A proposed rule revising the list of drug products that cannot be compounded
  • Final guidance for pharmacies or individuals intending to compound drugs

Furthermore, the FDA released several new draft guidance documents for amendments to abbreviated new drug applications (ANDAs), used for generic drugs. The draft documents explain the process for modifying an ANDA that has already been submitted and outline the expected timeframes for a response from the FDA after submitting an amendment.