Drugs

Continue Clinical Trial Drug Access After Trial: FDA

FDA commissioner Scott Gottlieb, CDER director Janet Woodcock, and CBER director Peter Marks are urging drug companies to offer expanded access to patients who have been in a clinical trial after the trial ends. In a statement, the three say that sometimes drugs that have not shown benefit across the overall study population may still be providing benefit for individual patients. “In such situations,” they say, “expanded access may have a role in allowing patients to have continued access to the drug. We would generally support such efforts. Providing expanded access to patients who undertook the risks that are inherent in participating in any clinical trial is an acknowledgement of the contribution these patients have made to the overall drug development program. Of course, in situations where an experimental treatment is potentially associated with substantial risk, and where the therapy has not been demonstrated to be effective in a trial, continued access must be carefully considered by the physician and the patient, and weighed by the sponsor, especially if further development of the drug is being considered.”

The FDA executives say that providing a drug under expanded access very rarely affects development timelines and they urge sponsors to consider access in appropriate settings, and especially after patients who are showing promise on an experimental drug complete therapy in a clinical trial setting.

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