This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
- The Upper Nasal Space: Drug Delivery’s Next Frontier
- India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
- Key Insights From The 2022 PDA/FDA Joint Regulatory Conference
- Calculating Process Capability Of Cleaning Processes With Completely Censored Data
- CDMO Selection In Our Post-COVID World
- Jump-Start Your Next CDMO Outsourcing Project With This Checklist
- FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics
The Upper Nasal Space: Drug Delivery’s Next Frontier
Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.
India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
Key Insights From The 2022 PDA/FDA Joint Regulatory Conference
Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
Calculating Process Capability Of Cleaning Processes With Completely Censored Data
Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.
CDMO Selection In Our Post-COVID World
In a post-pandemic world, we need to explore a broader view of our new reality. This article shares some of the concepts currently playing out in bio/pharmaceutical outsourcing that will impact your CDMO selection strategy. Additional discussion touches on how new outsourcing players will fit in and the path forward.
Jump-Start Your Next CDMO Outsourcing Project With This Checklist
Why does it take so much time between awarding a CDMO contract and initiating of the first activities at the CDMO? Once a project is granted, there are activities that you as the sponsor company can perform before, at, and after the traditional kickoff meeting for best success.
FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics
The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.
Autonomous Supply Chain Planning Is Within Reach
In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
PHARMA ONLINE WHITE PAPERS
How Dwell Volume And Extra-Column Volume Impact Method Transfer
Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
What Is Pharma 4.0 And How Can You Implement It?10/3/2022
How can you get drugs to market faster without sacrificing quality, all while saving time and money? Pharma 4.0 could be the solution.
mRNA Vaccine Development: Planning, Workflow, Supply Chain Success5/17/2022
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
Monkeypox Vaccine: What To Expect9/21/2022
We answer your most pressing questions about how the monkeypox vaccine works and how it’s manufactured.
Patient-Centric Oral Solid Dose Formulation5/17/2022
Gain insight into the systematic application of patient centricity to the design of OSD products.
Pharmaceutical Manufacturing: Monitoring And Maintaining A State Of Control4/21/2022
Companies must aggregate their data before they can monitor it. Learn how cost-effective, global process monitoring programs can make this process easier.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections