Drugs

Topics Suggested for Combination Products Policy Council

The Biotechnology Innovation Organization (BIO) says that FDA’s Combination Product Policy Council should develop recommendations for implementation of provisions introduced in the 21^st Century Cures Act, particularly recommendations to account for prior findings of safety and effectiveness or substantial equivalence for an approved constituent part. The organization also asks for more information about how the council will address product-specific inter-Center disagreements during a product’s review cycle.

Additional suggested topics from BIO include:

aligning recognized standards with pharmacopoeia or guidances, as a number of internationally recognized standards are not aligned;
how misaligned communication pathways for drug-led and device-led reviews limit the ability to interact directly with reviewers; and
pediatric development issues.

Johnson & Johnson’s response to FDA’s request for topics for the council to consider includes (1) implementation of Section 3038 of the 21^st Century Cures Act; and (2) a mechanism to review product-specific (application related) inter-Center disagreements during a product’s review cycle that can’t be resolved by the Office of Combination Products.

Finally, Pfizer says it has no specific topics to suggest and says that implementation of some existing programs and provisions in the next several years “ has the capability to substantially influence the way both FDA and our industry deal with combination products. Without fully understanding the extent and effect of these changes, Pfizer recommends that the council have oversight over the implementation and provide continued transparency to industry.”

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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