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Regulatory Update, February 2016

Monday, February 1, 2016

Draft FDA Guidance on Safety Assessment for IND Safety Reporting

In the Dec. 17, 2015, edition of the Federal Register, the FDA announced the availability of a draft guidance document titled Safety Assess­ment for IND Safety Reporting. The draft guid­ance provides recommendations to sponsors on developing a systematic approach to inves­tigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND. The draft guidance is a follow-on to the 2010 guidance for industry and investigators titled Safety Report­ing Requirements for INDs and BA/BE Studies that provides recommendations for how spon­sors of INDs can identify and evaluate impor­tant safety information that must be submitted to the FDA and all participating investigators, including a recommendation that sponsors de­velop a safety assessment committee.

There are recommendations on the follow­ing: the composition and role of a safety assess­ment committee; aggregate analyses for com­parison of adverse event rates across treatment groups; planned un-blinding of safety data; reporting thresholds for IND safety reporting; and the development of a safety surveillance plan.

It is critical for sponsors to detect and report, as early as possible, serious and unexpected suspected adverse reactions (SUSAR) and clin­ically important increased rates of previously recognized serious adverse reactions. Early detection of such occurrences will enable spon­sors to carry out their obligation to monitor the progress of the investigation and, when neces­sary, to take steps to protect subjects to allow an investigational drug to be safely developed de­spite potential risks. Early detection also allows sponsors to report meaningful safety informa­tion to the FDA and all participating investiga­tors in an IND safety report as soon as possible.

Timely reporting of meaningful safety in­formation allows the FDA to consider whether any changes in study conduct should be made beyond those initiated by the sponsor and al­lows investigators to make any needed changes to protect subjects. For those reasons, the draft guidance provides recommendations intended to help sponsors meet their reporting obliga­tions. The FDA recommends that sponsors develop a safety assessment committee and a safety surveillance plan as key elements of a systematic approach to safety surveillance. A safety assessment committee would be a group of individuals chosen by the sponsor to review safety information in a development program and tasked with making a recommendation to the sponsor regarding whether the safety infor­mation must be reported in an IND safety re­port. A safety surveillance plan should describe processes and procedures for assessing serious adverse events and other important safety in­formation.

Submit electronic or written comments by Feb. 16 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The notice includes detailed instructions on how to submit written comments with con­fidential information, if applicable; the instruc­tions should be followed carefully. Identify comments with Docket No. FDA-2015-D-4562.

Final FDA Guidance on Studies of Implantable Minimally Invasive Glaucoma Surgical Devices

In the Dec. 15, 2015, edition of the Federal Register, the FDA announced the availability of a final guidance document titled Premar­ket Studies of Implantable Minimally Inva­sive Glaucoma Surgical (MIGS) Devices. This leapfrog guidance document was developed to notify manufacturers of the recommended nonclinical and clinical studies to support a premarket approval application (PMA) for im­plantable MIGS devices.

The guidance document recommends non-clinical and clinical studies to support a PMA for implantable MIGS devices. Current surgi­cal treatments are aimed at reducing intra­ocular pressure and often reserved for moder­ate to severe disease. During the past decade, novel medical tools called “MIGS devices” have emerged. They are designed to treat less severe glaucoma by enhancing physiological aqueous outflow with an approach that causes minimal ocular trauma.

This document makes final the draft ver­sion of the guidance. The FDA received 12 sets of public comments and revised the guidance, where applicable. Multiple comments were received regarding the definition of glaucoma and the inclusion of pre-perimetric glaucoma. Based on discussion at the “FDA/American Glaucoma Society Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery,” Feb. 26, 2014, the FDA does not believe that pre-perimetric glaucoma (i.e., optical coherence tomography changes and optic nerve changes without any field abnormalities) should be included in those interventional studies because there are dif­fering opinions among experts about whether this condition warrants surgical treatment. The guidance is a “leapfrog” guidance; leapfrog doc­uments are intended to serve as a mechanism by which the FDA can share initial thoughts re­garding the content of premarket submissions for emerging technologies and new clinical ap­plications that are likely to be of public health importance very early in product development, generally before the FDA has even received any such submissions. It represents the FDA’s ini­tial thinking and the recommendations may change as more information becomes available. The current recommendations are designed to provide a conservative approach to protection of human subjects.

Submit electronic or written comments as instructed above and identify them with Dock­et No. FDA-2015-D-0288.

The Regulatory Update is excerpted from Research Practitioner, Volume 17, Number 1, January-February 2016.

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