Drugs

Bipartisan Patent Coordination Bill In

Sens. Charles Grassley (R-IA), Richard Durbin (D-IL), Thom Tillis (R-NC), Peter Welch (D-VT), and Chris Coons (D-DE) have introduced the Interagency Patent Coordination and Improvement Act to establish a task force between FDA and the U.S. Patent and Trademark Office to “improve communication and coordination in implementing each agency’s activities related to pharmaceutical patents.” A statement from the Senate Judiciary Committee, which Grassley chairs and on which all the bill’s sponsors serve, says the task force would:

enhance information sharing on each agency’s processes, standards, and methods;
improve dialog on new technologies and scientific trends;
enable confidential reciprocal access to information, if requested and only as needed, related to prior art;
ensure accurate representations by companies between the two agencies; and
ensure the accuracy of patent listings.

“The bill promotes efficiency and good governance,” the statement says, “by fostering communication between the two agencies, while respecting their distinct purviews. This enhanced coordination will help bolster innovation while preventing inappropriate tactics to delay access to affordable generic medications.”

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