Featured Pharma Online Editorial

  1. ISO 10993: Considerations For Drug Delivery Devices 12/4/2019

    A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.

  2. Improving Biopharma Packaging Line Efficiency Through Overall Equipment Effectiveness (OEE) 11/20/2019

    While the boipharmaceutical industry has benefited from high margins and low competition for decades, operational efficiency remains a low priority item for packaging departments in life sciences..

  3. Intro To Prefilled Syringe Selection: Staked-In Needles 10/15/2019

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  4. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices 9/30/2019

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  5. Examining FDA’s New Patient Labeling Draft Guidance 9/9/2019

    The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  6. Pharmaceutical Transport Validation — Where To Begin? 9/6/2019

    This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.

  7. Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods 7/11/2019

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

  8. DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box 6/27/2019

    The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?

  9. New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know 12/19/2018

    Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.