Drugs

CDER’s Top Priority is Informatic Process Management: Woodcock

CDER director Janet Woocock says that the Center’s top priority for 2017 is improving and implementing informatic process management across the whole center. Speaking in a Director’s Corner podcast, she said that a tremendous amount of effort is going into the program.

“We have set up a governance board we call the BIG (Bio Informatics Governance) and under that we will have the data standards effort, the standards boards, the change control boards, as well as process control boards and process governance as well as the IT that works into that,” she explained. “Now we’ve already implemented the platform in the generic drug review process and in other small processes around the Center. We hope in October to be implementing the platform in some parts of the new drug review process, and we hope to keep building on that.”

The second highest priority, she said, is to implement provisions of the 21^st Century Cures Act that affect CDER. She says an analysis of the provisions that involve CDER is underway and once it is completed, it will be necessary to put together working groups to start to make things happen.

Woodcock says that an important priority for her personally is to re-invent, reimagine, refresh or reinvigorate the new drug review process. Other priorities she cited include:

working on the opioid epidemic;
modernizing assessment of drug manufacturing facilities;
the new memorandum of understanding for drug inspections with the European Union;
the Oncology Center of Excellence; and
drug compounding.

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