The US Food and Drug Administration (FDA) issued a statement in support of their decision, with explanatory and cautionary information. At the same time, a joint statement against the approval was issued by multiple asthma patient advocacy groups and community stakeholders saying, in part, that the groups “believe the FDA’s decision endangers people with asthma […]
As with standard solid dosage forms, commercial DPIs are typically labeled with a label claim, which, in simple terms, is essentially the strength or dose of the product. For DPIs, however, the understanding of dose is more complex than for standard solid dosage forms because the entire labeled dose never reaches the target region of […]
This article focuses on the informative chapters that are either official text or are in draft, and fall under the remit of the sub-committee: <1601>, <1602>, <1603> and <1604>. The information provided on draft chapters and is based on previously published Stimuli articles, and should therefore be construed as only being indicative of likely content, […]
Now in its fifth year, the Teal Pumpkin Project is affiliated with Food Allergy & Research Education (FARE), a leading organization in the United States that works on behalf of people with allergies. The project is also extending beyond the US. The article describes easy steps to participate.
Patients who use inhalers and other stakeholders are eager for better solutions to improve outcomes. The most obvious and important benefit of connected inhalers is providing assistance for patients, which may increase their adherence. Connected inhalers may also help improve communication and treatment while reducing costs. In addition, potential benefits for and possible concerns of […]
Over the past decades, important progress has been achieved through the introduction of new capsule types and advanced particle engineering. A range of HPMC capsules with distinct properties as well as customizable specifcations have broadened the design space for cDPI systems. The use of spray-drying technology for advanced particle engineering allows the delivery of much […]
A study published in JAMA Pediatrics by Halterman, et al. evaluated 400 children with asthma in an impoverished school district. Small but statistically significant results showed that telemedicine combined with in-school care could play a key role in helping school-aged children with asthma manage their condition. The authors hope that such care models will continue […]
The National Youth Tobacco Survey (NYTS) is a pencil-and-paper questionnaire, self-administered in schools to a cross-sectional, nationally representative sample of students in grades 6-12 in the United States. Findings of the 2016 survey were analyzed by the United States Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA).
Establishing bioequivalence based on pharmacokinetic (PK) and clinical endpoint studies is challenging, given systemic drug concentrations may not correlate with local therapeutic response. The United States Food and Drug Administration’s (FDA’s) Generic Drug User Fee Amendments (GDUFA) initiatives support advancing regulatory science to determine equivalence of complex and locally acting topical dosage forms. These activities […]
This article discusses the basics of conventional nebulization technologies for inhalation therapy. It also presents novel approaches that have been implemented or may have the best likelihood for future use in miniaturization of conventional nebulizers and development of handheld, single or multiple dose nebulization systems.