FDA Policy/General

FDA Works With Pfizer on Animal Opioid Supply

FDA says it has worked with Pfizer to help alleviate a shortage of certain injectable opioids available to treat pain in animals. An agency statement says it is facilitating the availability of a limited amount of product labeled for human use.

The notice says that the Center for Veterinary Medicine became aware in September that veterinarians who relied on the products for pain control were no longer able to obtain them through their standard distribution channels due to a shortage of injectable opioids and to Pfizer’s decision to restrict distribution of such products for human use only during the shortage.

CVM met with Pfizer to raise awareness about the veterinary community’s need for injectable opioids, the notice says, and to discuss how a limited supply of product imported from other countries could be made available for use in the U.S. veterinary market,

Pfizer is making available hydromorphone hydrochloride injection and morphine sulfate injection to the U.S. veterinary market. The products are in short supply, FDA says, but will continue to be available to veterinary practitioners when supply increases.

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