Drugs

Late Petitions Can’t Delay ANDA Approval

FDA is publishing a final rule, which takes effect 1/9/17, that establishes new regulations for citizen petitions, petitions for stays of action, and the submission of documents to the agency to implement provisions of the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act that implement a congressional desire that petitions not be used to improperly delay approval of ANDAs. The rule notes that over the years, the agency has received numerous petitions asking it not to approve a particular ANDA or 505(b)(2) application, or classes of these applications concerning a particular drug product or active ingredient, unless certain criteria set forth in the application are met. In many cases, it says, the petitions raised scientific and/or legal issues relating to the standards for approval of an application.

“When submitted early, such as when we are making decisions about the bioequivalence requirements for a generic drug product or before we have received the first ANDA, 505(b)(2) application, or 351(k) application for a drug or biological product, a petition may contain information that can contribute towards our evaluation of an application,” FDA says in the rule. “However, when petitions are submitted late in the review process for challenged applications and do not raise valid scientific and/or legal issues, they may have the effect of improperly delaying the approval of an application.”

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