Infusion Drug Delivery Resources
-
Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
1/24/2022
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
-
Formulation Research Strategy For Discovery- Stage New Drug Candidates
1/24/2022
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
-
Hospital To Home: What It Means For Patients, Providers And Medical Devices
4/16/2025
Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.
-
Navigating Regulatory Challenges In Oligonucleotide Therapeutics
12/12/2024
Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
-
Contract Design And Development Vs. In-House: How To Find The Best Fit
3/21/2024
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
-
Starting The IV: Why Autonomous Cannulation Could Be The Next Step In Critical Care
5/13/2026
As care shifts beyond hospitals, IV access is a bottleneck. Autonomous cannulation could ease labor shortages while improving speed, consistency, and access to IV therapy across settings.
-
Formulation Development From Preclinical To First-In-Human
1/24/2022
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
-
Small Is Powerful And Sustained
Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
-
Wearable Injectors: An Alternative To Traditional Intravenous Administration
3/24/2022
See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
-
Data-Driven Innovation Is Drug Delivery's Next Evolution
7/23/2025
To mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.