Drugs

CDER Office of Surveillance and Epidemiology MAPP

CDER has issued a Manual of Policy and Procedures (MAPP) for its Office of Surveillance and Epidemiology (OSE) with the procedures for sharing non-public information on pending proposed drug proprietary names. The procedures are to be used by the OSE Division of Medication Error Prevention and Analysis and the Safety Regulatory Project Management staff when an OSE evaluation identifies that two or more proposed proprietary drug names submitted in pending applications are so similar that they could cause confusion resulting in medication errors. In such circumstances, the MAPP says, with the consent of the application holders, OSE will share certain information that may be non-public with the affected application holders. “The information will be shared for the sole purpose of facilitating discussions between the affected application holders regarding the naming conflict(s),” it says.

The information that could be shared covers the name of the affected application holder and the name, title, and contact information of an authorized representative for each of the affected application holders, according to the document.
“This process reflects the fact that once an IND or an application is filed with a proposed proprietary name that conflicts with a previously filed IND or an unapproved application, both proposed proprietary names are ‘unacceptable’ until one application is approved, regardless of which application was filed first,” the MAPP says.

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