Drugs

CDER Implementing Drug Regulation Modernization

CDER director Janet Woodcock says agency efforts to modernize its drug regulatory program “will reach a crescendo in 2019 when we’ll be going into implementation. So we’ll begin to see a lot of changes, and I call on all of you for your help and assistance in making this happen and also your good will because I think these are going to be extremely positive changes.” Woodcock made the comments in her latest Director’s Corner podcast.

She says CDER will be rolling out the new review process for NDAs and BLAs with the new documentation in a staged fashion. “This envisions a multidisciplinary team review and documentation,” she says, “and I think it’s a very, very exciting change for how we do things. The review and documentation will be issue-based, so we will go through the issues in detail in how they were resolved and what our regulatory conclusions were. In addition, we expect toward the end of the 2019 fiscal year that we will have a reorganization approved. Of course, we can’t guarantee that, but we hope that, in which case, there will be multiple changes within the Office of New Drugs and, also, some corresponding changes in other offices.”

In the podcast, Woodcock also updates efforts to address drug shortages, address compounding issues, deal with the contamination of some blood pressure medicines, reform the OTC monograph program, and cope with the opioid crisis.

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

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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