Drugs

More Steps to Help Compounders Register for Outsourcing

FDA commissioner Scott Gottlieb says the agency will be taking additional steps in the coming months to help more drug compounders register as outsourcing facilities. In a statement, he said the actions will include continuing to streamline the process and to appropriately calibrate the regulatory burden of operating as an outsourcing facility.

“Appropriately compounded drugs can provide important alternatives for patients who need them,” Gottlieb wrote. “Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process.”

The statement came as the agency released a new guide compiling key regulatory information applicable to outsourcing facilities, including information about the implications of becoming an outsourcing facility, the agency resources available to outsourcing facilities, registration and product listing, and FDA inspections and subsequent actions.

FDA also posted a report listing drugs that entities registered as outsourcing facilities have produced. Under the Drug Quality and Security Act, outsourcing facilities are required to report to FDA upon initial registration and each June and December the drug products that they compounded during the previous six months.

“We are making the list public, among other reasons, to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards,” Gottlieb said.

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