Drugs

Priority ANDA Guidance Seeks Excessive Info: Teva

Teva says that an FDA draft guidance on pre-submission facility correspondence associated with priority ANDA submissions seeks information that goes above and beyond what was included in the commitment letter for reauthorization of the Generic Drug User Fee Act. “The pre-submission facility correspondence guidance exceeds the details included in the commitment letter by stating that a ‘thorough’ description of the manufacturing process should be included, whereas the commitment letter only calls for ‘a description of the manufacturing process,’” Teva writes in a comment letter. The company says that as a result of the draft guidance, the correspondence in its current form will be a deterrent to ANDA filers, thereby eliminating the intent for a shorter review for those applications that would bring benefit to the U.S. healthcare system by speeding access and competition in the market. It asks FDA to revise the draft guidance to remove language and requirements that are above and beyond what was negotiated and agreed with industry and included in the commitment letter. The company includes other line-by-line 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