Drugs

More FDA Transparency on NDA Submissions/Rejections: Lurie

FDA needs to be more transparent and announce when companies submit NDAs to the agency, according to Center for Science in the Public Interest and former associate commissioner Peter Lurie. Reacting to new FDA research on NDA notifications published in JAMA-Internal Medicine, Lurie says it makes “no sense for the FDA to keep the filing of new drug applications secret from the public at the same time the drug companies are putting out press releases about them.” Lurie is a co-author of the JAMA article and he was at the agency when the research was undertaken.

While FDA typically treats the existence of NDAs as confidential commercial information, not even acknowledging that they have been filed, the research finds that almost 90% of such submissions filed between 2010 and 2016 were disclosed by drug companies in press releases, filings with the Securities and Exchange Commission, or both—and typically within a week of the submission being made.

Lurie also calls on FDA to make public the rejection letters or complete response letters it sends sponsors when pending drug applications are not approved. Presently, FDA only discloses drug decisions that permit a drug to be marketed and not decisions that deny it.

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