Drugs

FDAers Look at Oncology Drug Clinical Holds

Six CDER staff members say that in the Center’s Office of Hematology and Oncology Products, less than 10% of INDs went on hold or were withdrawn within the 30-day safety review period. In an article to be published in Regulatory Toxicology and Pharmacology, the researchers report that of the INDs that were placed on hold, deficiencies were mainly clinical, followed by concerns related to pharmaceutical quality and nonclinical development.

The research was conducted to quantify the most common reasons that INDs for oncology indications go on clinical hold.

In the study, INDs were also characterized based on phase of development, product type, sponsors’ regulatory experience, and occurrence of a pre-IND meeting. The study showed that INDs that were placed on hold were mostly for first-in-human trials or were submitted by sponsors with limited regulatory experience. INDs that went on hold or were safe-to-proceed had pre-IND meetings with comparable rates, but sponsors with substantial experience appeared to benefit more from pre-IND meetings to those with limited experience.

The time interval between the pre-IND meeting and the IND submission was longer for INDs that went on hold, the article says. The researchers say that to obtain useful FDA feedback on product development, it is essential to provide focused questions and supporting information in pre-IND meeting packages.

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