FDA Policy/General

Some Promotions Need Longer Review: OPDP

CDER’s Office of Prescription Drug Promotion (OPDP) says that while its goal is to provide comments on draft promotional materials within 45 days of the voluntary submission of the materials by sponsors, some recent draft materials “have raised complex issues that required additional review, resulting in review times that exceeded the 45-day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past.”

The statement is included in an inline post of OPDP tracking metrics. The post also shows that OPDP has generally preliminarily reviewed and complaints about potentially false or misleading advertising within 30 calendar days of receipt. Finally, it shows that the number of promotional material submissions and the volume of materials within submissions increased steadily from 2014 to 2018.

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