Drugs

Certificates of Confidentiality Final Guidance

FDA has issued a final guidance on Certificates of Confidentiality, which describes the agency’s implementation of revised provisions under the 21st Century Cures Act (Cures Act). A Certificate of Confidentiality (CoC) is intended to help protect the privacy of human subject research participants when identifiable, sensitive information is being collected or used in clinical research. The Cures Act simplified certain aspects of the issuance of CoCs by requiring that they be issued for federally-funded human subject research that collects or uses identifiable and sensitive information, the agency says. For non-federally funded research, CoCs are not required but may be issued at the discretion of FDA, it says.

“A CoC generally protects a researcher from being compelled to disclose identifiable, sensitive information about the research participant, created or compiled for purposes of the research, in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding,” the guidance says. “As amended, the statute broadened these protections by prohibiting disclosure of such information. By protecting researchers from being compelled to disclose identifiable, sensitive information about the research participants, CoCs help protect the identity of the research participants and achieve the objectives of the research.”

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

Read more

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