Drugs

FDA Co-sponsors PBPK Drug Modeling Conference

FDA and the American Society for Clinical Pharmacology and Therapeutics are co-sponsoring a 3/13 conference on “PBPK Modeling for the Development and Approval of Locally Acting Drug Products.” In announcing the conference, the agency says “recent advancement of physiologically-based PK (PBPK) models for drugs delivered directly to sites of action in the skin, lung, eyes, nose, or gastrointestinal tract, can aid in product development and identifying the most efficient bioequivalence (BE) studies. Demonstrating BE for generic locally-acting drug products is challenging because local drug concentrations at the site of action may not be measured directly and systemic drug exposure may not be reflective of local drug delivery at the site of action. PBPK models that integrate information about both the physiological systems and the drug product to make predictions about biodistribution of locally acting drug products have the potential to be an integral part of the development and approval of generic locally acting products.”

The conference will:

Discuss the challenges and role of PBPK for locally acting drug products in regulatory decisions
Address challenges and opportunities for PBPK use with inhalation drugs, dermal drug delivery and ophthalmic drugs
Discuss challenges and opportunities for the science community in advancing PBPK models

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