Drugs

CDER Program Helping Companies Innovate: Post

A Genetic Engineering and Biotechnology online post says that the CDER Emerging Technology Program is helping biotechnology and pharmaceutical companies innovate and still negotiate any regulatory steps as easily as possible. CDER Emerging Technology Team (ETT) director Sau Lee is quoted in the post as saying that the program employs a combination of early engagement, face-to-face meetings, FDA site visits, integrated quality assessments, and pre-approval inspections. “The same ETT representatives that engage with the company will likely be involved in the entire process,” he said.

Companies that are accepted in the program can get early agency feedback about their emerging technology even before a drug or product candidate has been associated with the technology, Lee said.

Technologies that companies have inquired about, Lee said, include controlled ice nucleation for lyophilization processes; comprehensive product testing using a single multi-attribute assay; continuous manufacturing for a downstream process; end-to-end integrated bioprocess; and small manufacturing platforms for continuous bioprocesses, such as pharmacy on demand.

“A company gets a forum for early dialog with FDA to support innovation; identification of potential roadblocks relating to existing guidance, standards, policy, or practice; and consistency and continuity in assessment and inspection,” Lee said.

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