Drugs

Changes Sought in Device Essential Outputs Guide

The Combination Products Coalition (CPC) says FDA should change its draft guidance on essential drug delivery outputs (EDDOs) for devices intended to deliver drugs and biological products to offer companies greater flexibility in determining how to implement the concepts in the guidance. “In particular,” the coalition comment letter says, “we recommend that FDA acknowledge that companies may document the drug delivery functions that are described within the draft guidance as ‘EDDOs’ as either design inputs and/or design outputs within their individual quality management system structures depending on their individual design control and device development processes.”

The letter says such an approach would not only allow for more seamless adoption of the draft guidance across industry, but also allow it to more closely reflect the iterative transition of design inputs into design outputs through the design process.

CPC also calls on the agency to host or actively participate in public forums to discuss and receive input on its recommendations and key elements in the draft guidance.

The Association for Accessible Medicines says a better understanding of FDA’s expectations is critical for applicants to effectively design their testing strategies and to minimize the risk of avoidable review issues. It also expresses concern about the draft’s treatment of sequential preconditioning.

Pharmaceutical Research and Manufacturers of America recommends clarification or revision of these aspects of the guidance:

how the recommendations for EDDOs in the draft relate to FDA expectations for other aspects of drug delivery devices;
the preconditioning steps FDA recommends for EDDO design verification;
whether and how the guidance recommendations and requirements are consistent with the substantial equivalence standard for 510(k)s and class 2 devices;
the circumstances under which EDDOs need to be verified and validated before or within the clinical study;
expectations for ANDAs or 351(k) BLAs for combination products with drug delivery device constituents;
information to provide in IND and IDE applications; and
addition recommendations on EDDO control strategies.

The Biosimilars Forum submitted specific line-by-line comments, as did the other three stakeholders.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome