Drugs

U.S. Reassures Canada on Drug Imports

Health Canada says U.S. officials have reassured Canadian health minister Mark Holland that the U.S. does not intend to create any challenges for that country on drug access or shortage through FDA’s approval of a Florida program to import drugs from Canada. FDA approved the Florida plan 1/5 and Holland immediately raised concerns.

In the latest Health Canada statement, Holland says he spoke to HHS secretary Xavier Becerra and U.S. ambassador to Canada David Cohen about the issue. He says he reiterated to them the government of Canada’s commitment to protecting domestic drug supply and received assurances that the U.S. does not intend to create drug challenges for Canada. Holland says the three agreed to maintain open lines of communication.

“I want to assure Canadians that they will continue to have access to medications they need when they need them,” Holland concluded. “Canada has strong regulations in place to protect supply. Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”

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