Biologics

Comments on Patient-Reported Outcomes Guidance

The Biotechnology Innovation Organization (BIO) says it appreciates efforts by CDRH and CBER to develop a guidance on patient-reported outcome (PRO) instruments for use in medical product evaluation. BIO’s comment letter says that while PROs are an important tool for collecting and reporting patient experiences, the trade group believes that a patient-centric approach to drug review includes additional clinical outcome assessments. It encourages CDRH and CBER to consider the other types of outcome assessments, such as observer, clinician, and performance, when finalizing the guidance.

AdvaMed said it supports the development of the draft patient-reported outcomes guidance as a step toward meeting the MDUFA 5 commitment letter. “However,” the association writes, “the guidance should be strengthened to include examples of least burdensome ways in which existing broad PRO instruments can be used for other subpopulations without having to conduct cognitive debriefing or validation. Given the cost and time associated with revalidating PRO instruments, we also recommend that the guidance include several examples of the types of modifications that would require revalidation of the PRO instrument for cohorts that differ from the original PRO instrument cohort as well as other modifications that may be appropriate to implement an existing PRO instrument without extensive revalidation of the entire instrument.”

Otsuka submitted a specific technical comment.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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