Featured Editorial
-
Biochips: The Small Devices With Big Promise
11/14/2023
Biochips are small medical devices with microarrays for carrying out biochemical processes. Biosensors enable the screening of different biological materials like enzymes, proteins, DNA, biological molecules, and more, and are used in drug discovery and research. They can also be implanted in the body for targeted drug delivery or to track health data.
-
Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges
11/7/2023
Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.
-
FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance
11/2/2023
As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.
-
FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products
10/31/2023
Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.
-
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
10/27/2023
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
-
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1
10/6/2023
All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.
-
Emerging Market Trends For Drug Delivery Devices
10/5/2023
The market for drug delivery devices is growing and it is estimated to reach a market size of $541.5 billion by 2035. This article shares new market research, including segmentation by product type (inhalers, smart pills, drug-eluting stents, and more), routes of administration, regional analysis, and more.
-
Emerging Trends In Infusion/IV Therapy
9/20/2023
The infusion therapy market in the U.S. is growing rapidly, driven by an aging population and the increasing prevalence of chronic diseases. This article shares new market research, with a look at macro trends as well as trends in infusion pumps, IV sets, needleless connectors, stopcocks, IV filters, and blood transfusion sets.
-
Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
-
Global Market Trends For Drug–Device Combination Products
9/12/2023
Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.