NORD’s Rare Diseases and Orphan Products Breakthrough Summit
As major changes to the nation’s healthcare system are debated, the NORD Summit, which historically features more than 20 speakers from FDA and more than 80 thought leaders from the patient community and industry, will provide a unique opportunity to hear from the experts and join the conversation on issues of unprecedented importance. For more information on the event, visit the conference website.
| ||||||||||||||||||
| ||||||||||||||||||
|
|---|
|
Current Issue
STR Profiling: Authentication of Human Cell Lines and Beyond
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
Laboratory Data Integrity Benefits from Electronic Systems
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Outsourcing
Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved and changed over the years and what does the future hold?
CordenPharma, GE Healthcare Partner to Speed Development
GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.
Lonza Completes Capsugel Acquisition
A $5.5 billion acquisition brings Capsugel’s oral dosage delivery capabilities to Lonza’s portfolio.
Patheon Invests $45 Million in Facilities
Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.
Standards/Regulations
Industry Groups Applaud House Passage of FDARA
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
FDA Warns India Facility Over Sterility Failures
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Woodcock Sees Future for Precision Medicine
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
Webcasts
Sponsored Links
