USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
News|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Is Global Regulatory Gridlock Slowing Modernization?
Author(s)Agnes Shanley
PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.
Advertisement
PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology. Fewer pharmaceutical companies even do “technology scouting” today.
Maik Jornitz, who chaired the aging facilities taskforce during its first year, discusses challenges and what is required for change.
Download Pharmaceutical Technology’s
.
Articles in this issue
almost 10 years ago
Extending QMS to Contract Partnersalmost 10 years ago
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?almost 10 years ago
Ensuring Quality in Pharmaceutical Raw Materialsalmost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
Related to this article
Coverage from AAPS PharmSci 360 and CPHI Milan featured discussion about impurities, devices, and supply resilience. This week also included topics such as AI accountability, oral peptides, and new licensing deals.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
What the First Factor XIa Approval Means for Developers
2
CDMOs, OEMs, and Used Equipment Resellers are Joining Forces to Onshore Pharmaceutical Manufacturing
3
France Remains One of Europe’s Leading Biotech Funding Hubs
4
Our Biggest Takeaways From AAPS PharmSci 360
5