Drugs

Smart Women’s Choice Marketing Unapproved Contraceptive: FDA

FDA says its review of a Web site and social media sites maintained by Smart Women’s Choice, La Jolla, CA, indicate that the company markets its Smart Women’s Choice vaginal contraceptive cream that is legally considered to be a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. A 5/19 Warning Letter relates some of the claims made on the firm’s Web site and social media pages that establish the product as a drug.

FDA says the product is not generally recognized as safe and effective for its referenced uses and therefore is considered a new drug that cannot be introduced into interstate commerce without prior approval from the agency. “There are no FDA-approved applications in effect for your product,” the letter says.

Smart Women’s Choice was told to respond with a list of specific steps it has taken to address any violations, with documentation of each step and an explanation of how it will prevent the recurrence of violations, and a timetable for completing the work.

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