Drugs

Teva Raises BA/BE Retention Sample Compliance Policy Concerns

Teva says it appreciates FDA publication of the compliance policy for the quantity of bioavailability and bioequivalence samples retained under regulations. In a 1/5 comment letter, it notes that the requirement to have each reserve sample contain a sufficient quantity so that FDA can perform five times all the release tests required in the application has been burdensome to the company and likely to other drug sponsors.

Teva says it appreciates the agency’s policy of granting enforcement discretion for retaining fewer reserve samples of the test article and reference standard than is specified in the regulations for drug products manufactured in single-dose units as well as those in multi-dose units.

The company raises three additional concerns with the policy: (1) there still are products or situations that are not explicitly covered or referenced by the policy, leaving the industry uncertain as to whether the policy applies; (2) there are some situations where even under the more lenient retention standard the costs and burdens on Teva and the rest of the industry are significant; and (3) there appears to be a contradiction between the expectations for nasal aerosols and nasal sprays in multi-dose units laid out in the policy and the expectations for those products in a 5/2004 guidance.

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