The regulatory environment surrounding IV therapy and med spas has become fragmented. In some states, the definition of compounding has been expanded.
- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
- Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection
- Takeda Cut Its PPQ Timeline With beePFS — Here's How
- Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
- Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
- Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
- Bacterial Endotoxin Testing, Part 1: Overview
ON-DEMAND WEBINARS
Watch this webinar to hear Steven Facer, Adare's Vice President of Business Development EU/ROW, discuss challenges of pediatric oral solid dose manufacturing and how to overcome them.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Women using auto-injector syringe-GettyImages-1184225794]( "The Impact Of PFAS Regulations On Drug Delivery Devices")
The Impact Of PFAS Regulations On Drug Delivery DevicesBy adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.
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![BD Medical - Libertas Feature]( "Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics")
Innovation For Subcutaneous Delivery Of Large-Volume Complex BiologicsExplore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.
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![Pharmaceutical Tablets GettyImages-610221624]( "An Easy-To-Swallow Depression Drug For Elderly Patients")
An Easy-To-Swallow Depression Drug For Elderly PatientsExamine how an innovative formulation approach helped a developer create a version of their drug that promotes treatment compliance within the geriatric population.
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![Improved Bioavailability Of Trio Medicines In 12 Weeks]( "Improved Bioavailability In 12 Weeks")
Improved Bioavailability In 12 WeeksA lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured 3-step approach.
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![Patent Trolls]( "The Largest LOE Event In US Pharma History")
The Largest LOE Event In US Pharma HistoryAhead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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![Argonaut]( "3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing")
3 Keys To Rare Disease Clinical, Commercial Drug Product ManufacturingThe complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.
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![GettyImages-1426603202-scientist-research-lab]( "Application Of A Novel Temperature Shift Process For Particle Engineering")
Application Of A Novel Temperature Shift Process For Particle EngineeringSpray drying of amorphous dispersions improves solubility and bioavailability that enables supersaturation in the intestine, driving higher rates of absorption when compared to crystalline drug forms.
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![Enabling Long Lasting Clinical Outcomes In Coronary Stenting]( "Enabling Long Lasting Clinical Outcomes In Coronary Stenting")
Enabling Long Lasting Clinical Outcomes In Coronary StentingPolyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).
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![Capture]( "Finding The Ideal Balance — Where Risk And Cost Of Quality Meet")
Finding The Ideal Balance — Where Risk And Cost Of Quality MeetIt is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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![GettyImages-1294339670-lab-cleanroom-PPE-computer-team]( "Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations")
Simultaneous Spray Drying For Combination Dry Powder Inhaler FormulationsThree combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
Tom ensures that Drug Delivery Leader provides you with indispensable resources for staying current on the industry’s most innovative thinking. Get in touch today!
In her new column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "Preparing For The FDA QMSR: Will You Be Ready?")
The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance.
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
- Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
- Embrace Packaging and Delivery Systems Designed for Today's Standards
- The Key to Regulatory Innovation? Global Harmonization
- Organizational Imperatives For Combination Product Development
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
