Drugs

CDER Working to Optimize Drug Absorption

CDER scientists are working on ways to improve the bioavailability of drugs that do not dissolve well in water on their own. An Impact post describes research exploring the potential for using amorphous solid dispersions to formulate generic drug products that may include poorly water-soluble ingredients.

“Understanding the supersaturation and precipitation behavior of poorly water-soluble compounds in vivo, and the impact on oral absorption, is critical to designing consistently performing drug products with desired absorption into the body,” the report says…. “This research explores the current mechanistic understanding and prediction of in vivo performance of amorphous solid dispersion drug products for test and reference drugs. This research may be valuable for the development of generic drug products used to treat diseases such as cancer, cystic fibrosis, and heart, liver, and lung transplant rejection.”

The post says a better understanding of the process gained from the research will be critical to guide the regulatory assessment and evaluation of test drug products regarding the risk of not being bioequivalent compared to their reference standard.

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