Drugs

CMC Guidance Clarifications Sought

The Biotechnology Innovation Organization (BIO) says that FDA could minimize ambiguity when it finalizes a draft guidance, “Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports,” by giving examples of situations where annual reportable listed changes in the guidance may be better categorized by applicants as a supplement, based on specific circumstances. The group’s comment letter also says it would be helpful for the agency to acknowledge and confirm that a sponsor can perform an impact assessment to determine if a proposed change may be reported in an annual report, even if the proposed change is not listed in the guidance. BIO includes other general comments and specific line-by-line comments.

The Pharma & Biopharma Outsourcing Association says the guidance does not define opportunities for postapproval change regulatory relief, such as allowing more annual reportable changes versus changes-being effected-type changes, related to such initiatives as the agency’s draft guidance on quality metrics. The association says it recommends that the draft guidance could be used to outline FDA’s philosophy on reduced postapproval change regulatory requirements.

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