Drugs

FDA Decision on Florida Drug Imports Delayed: Report

A Florida public broadcasting station says documents filed by state officials in a Florida federal court indicate it is unlikely FDA will meet its previously stated intention to rule by 10/31 on a Florida proposal to import some drugs from Canada for use in government programs such as Medicaid, the prison system, and facilities run by the state Department of Children and Families. The state reportedly revised its Section 804 Importation Program proposal recently in response to FDA questions and concerns, the report says. A court document filed on 10/23 says the two sides were discussing a proposal to continue a court-ordered pause in a state suit alleging FDA violation of the Administrative Procedures Act due to delays in ruling on the Florida application. The filing said the brief additional pause would give FDA time to review the state’s revised proposal and that state officials were confident the agency would approve the proposal.

The broadcaster says one of the issues FDA raised pointed to the state’s proposal lacking a secured warehouse within 30 miles of an authorized port of entry for prescription drugs from Canada. The only authorized point of entry is Detroit, it says, and Florida had planned to store shipments at a facility in Whitestown, IN. There reportedly also have been discussions about the labeling of the imported drugs.

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