Drugs

Guide on Drug Study Safety Reporting Requirements

FDA has posted a draft guidance on Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. The document provides recommendations to help sponsors comply with the expedited safety reporting requirements under an IND or as part of a bioavailability or bioequivalence study that is exempt from IND requirements. It defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors.

The agency says the guidance also merges content from the final guidance entitled Safety Reporting Requirements for INDs and BA/BE Studies (12/2012) and from the draft guidance entitled Safety Assessment for IND Safety Reporting (12/2015). It includes revised recommendations initially described in the 2015 draft guidance on the following topics: (1) planned unblinding of safety data and implications for trial integrity; (2) increased flexibility regarding the party 37 reviewing aggregate safety information for IND safety reporting purposes; (3) clarification regarding the scope and methodology of aggregate analyses; and (4) clarification regarding the plan for safety surveillance, including what elements should be included in the plan.

The 2015 draft guidance has been withdrawn upon the publication of this guidance.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