Drugs

Meeting on Possible OTC User Fee Program

FDA says it will hold a 6/10 public meeting to hear stakeholder input on the potential development of a user-fee program for nonprescription over-the-counter monograph drugs. A Federal Register notice says that such a program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient agency review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

The notice says that the OTC monograph drug review process remains one of the largest and most complex regulatory programs ever undertaken by FDA. There are some 88 simultaneous rulemakings in 26 broad therapeutic areas encompassing hundreds of thousands of products. There are about 800 active ingredients for over 1,400 different therapeutic uses.

“FDA needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner,” the notice says. “Additional resources would also better enable the agency to consider innovations for drug products containing monograph ingredients, such as the development of new dosage forms for ingredients under existing monographs.”

The agency is asking stakeholders to comment in particular on the types of user fees (such as product listing fees, facility fees, application fees, and other types) that might be appropriate for a potential monograph user fee program, and on types of FDA performance goals that might be important to consider from a public health and sponsor perspective.

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