Drugs

Name NIH in Drug Patent Applications: GAO

The Government Accountability Office (GAO) says the National Institutes of Health (NIH) can do a better job of ensuring that recipients of funds for research and development of FDA-approved drugs acknowledge the government’s role in their work. Members of Congress asked GAO to review how NIH-funded biomedical research and development contributes to drug development. FDA is cited in the report for its role in drug approvals.

The report says NIH awardees did not consistently disclose NIH support in patents arising from research into FDA-approved drugs funded by the agency. “NIH does not provide clear guidance that its awardees should name NIH as the funding agency and correctly identify the award number when disclosing NIH support in patents,” GAO found. “The disclosure of federal support informs the public and other interested parties of the federal government’s involvement.”

GAO recommends that NIH guidance clarify that awardees should name NIH and include the NIH award number when disclosing the agency’s support in patent applications. NIH concurred with the recommendations, it says.

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