Drugs

Public Meeting on Trial Inclusion/Exclusion Criteria

FDA and Duke University’s Center for Health Policy have announced a 4/16 public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will help the agency develop a guidance on the subject. It will include discussion about various ways in which participation in clinical trials can be improved, including through alternative trial designs and expanded access trials. Other topics for discussion include:

the risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation
the rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, children, pregnant and lactating women, elderly, individuals with advanced disease, and individuals with co-morbid conditions
alternative clinical trial designs that may increase enrollment of more diverse patient populations
how appropriate patient populations can benefit from the results of trials that employ alternative designs
how changes to eligibility criteria may impact the complexity and length of clinical trials, as well as the strength of data necessary to demonstrate safety and effectiveness
opportunities for using data from expanded access trials

To view more information about the meeting, click here.

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