FDA Publishes Two Guidance Documents, One in Final Version

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FDA announced the publication of a pair of guidance documents, one as a draft and one in its final form, on Jan. 7, 2025 (1,2). The deadline for comments on the draft guidance to be considered for its final version has been set for April 8, 2025 (2).

That guidance, “Developing Drugs for Optical Imaging,” concerns those drugs which are used in conjunction with imaging devices, intended as intraoperative aids either for detection of pathology (i.e., tumors), or to enhance conspicuity for otherwise normal anatomical structures (2).

As its name suggests, optical imaging uses light in conjunction with imaging drugs and devices, and FDA considers its guidance necessary because of a “burgeoning interest” in development of novel drugs and devices to further assist in a variety of standard surgical procedures (2).

Meanwhile, the final guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers,” bears the same title as a revised draft guidance from October 2023, which in turn replaced a draft guidance issued as far back as March 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices”—itself replacing a previous final guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” issued in January 2009 (1).

Through its many incarnations, FDA summarized the present form of this document by saying it intends to describe the agency’s enforcement policy when it comes to communications of scientific information initiated by firms, detailing unapproved uses of those firms’ medical products to healthcare providers (HCPs) who are tasked with prescribing or administering the products to patients, whether or not the products are cleared or approved. However, FDA said pending a decision by its Office of Management and Budget on collection of certain information, the final guidance is not meant for current implementation.

“A firm’s communication about unapproved uses of its approved/cleared medical product could be evidence of the firm’s intended use for such product, and, depending on the facts and circumstances, may be relevant to establishing that the firm has distributed a medical product that fails to comply with applicable premarket requirements or is otherwise misbranded or adulterated,” the guidance says (1). “At the same time, in certain circumstances, HCPs may be interested in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care and management of their individual patients.”

FDA reminded the public, in both cases, that online or written comments can be submitted on any guidance at any time, even if the guidance is considered “final” (1,2).

References

1. FDA, Guidance for Industry, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical ProductsQuestions and Answers, Revision 2 (CDER/CBER/CDRH/CVM/OC, January 2025).
2. FDA, Draft Guidance for Industry, Developing Drugs for Optical Imaging (CDER/CDRH, January 2025).