Drugs

PhRMA Comments on FDA Safety Reporting Guide

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s ongoing efforts to advance investigational drug safety reporting and provide guidance about sponsor responsibilities for safety assessments. In a 9/24 comment letter on an agency draft guidance, Sponsor Responsibilities — Safety Reporting Requirements for IND and Bioavailability/Bioequivalence Studies, PhRMA says it appreciates that FDA has incorporated earlier comments from PhRMA and other stakeholders in the draft and has held multiple meetings on the subject.

“PhRMA agrees with FDA that a plan for safety surveillance should include clearly defined roles and responsibilities of the entities and participating individuals that have responsibility for any or all of the following: reviewing, analyzing, and making decisions regarding IND safety reporting,” the letter says. “This appropriately enables flexibility for sponsors in developing a prospective and systematic approach to safety assessments and reporting that is specifically tailored to the complexities of each individual drug development program.”

The association says it also agrees with the agency’s approach in the draft guidance regarding unblinding trigger rates.

PhRMA provides specific line-by-line comments and edits as well as its general comments.

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