Drugs

Some Guidance Changes Helpful, More Needed: AAM

The Association for Accessible Medicines (AAM) says that while some FDA changes to a draft guidance on pre-submission facility correspondence (PFC) related to prioritized generic drug submissions are helpful, it believes that additional changes are needed. The association’s comment letter says the revised draft guidance provides some additional explanations for why certain information is requested in a pre-submission facility correspondence, but AAM believes the rationale is flawed in some respects and still is not granular enough for applicants to fully understand why some of the requested information is necessary.

“FDA should critically examine each of the items requested to be provided in the PFC with an eye towards paring down the items to only those that are absolutely necessary for FDA to determine whether an inspection must be conducted,” the letter says. “For each of the items requested to be provided in the PFC, FDA should provide the rationale for why it is necessary.” The association also submitted specific line-by-line comments.

The Apotex comment commends the agency for working with industry to address industry’s concern regarding the information required for a PFC to be considered complete and accurate. “By reducing the information required and adopting a more flexible approach, the agency has made it more feasible for applicants to utilize the PFC option,” Apotex says. The company also submitted specific comments.

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