Drugs

CDER Research Helping Generic Inhaler Development

CDER says its researchers are helping to develop more realistic laboratory models of the mouth-throat region that allow the generic drug industry to efficiently test their metered-dose inhaler (MDI) products and speed access to generic products. A Center Impact Story says experiments in a recent study measured the effect of in vitro test variables on the particle size distribution of aerosols exiting an anatomical mouth-throat model and may improve the predictability of in vivo lung disposition that could accelerate the development of generic as well as branded drug inhalers.

Five factors were examined in the study, the post says, including different geometry and sized mouth-throat models; inhalation profiles representing strong, medium, and weak inhalation; two commonly used mouth-throat model coatings; MDI insertion angles; and two MDI firing points after the start of inhalation profiles.

The researchers concluded that during the development of inhalers, applicants who use more realistic in vitro studies should consider how the experimental conditions, particularly the mouth-throat model type and inhalation profiles, affect the amount and particle size distribution of aerosols exiting an anatomical mouth-throat model when designing their studies.

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

Read more

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