Regulatory Roundup for the Week of March 11, 2013 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup for the Week of March 11, 2013


FDA has issued a draft guidance document for the manufacture of products that are not made with natural rubber latex (NRL). FDA is recommending that manufacturers use the statement “not made with natural rubber latex” instead of “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate.  FDA says the terms “latex free” and “does not contain natural rubber latex” suggest that the medical product is completely without NRL when there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes. “Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, MD, MPH, deputy director for science in the FDA’s Center for Devices and Radiological Health, in a press release. “Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy.”

FDA’s Center for Drug Evaluation and Research released its publishing agenda for guidance documents for the rest of the year. Included on the agenda are guidance documents on quality systems for CGMPs; contract manufacturing arrangements for drugs; and pharmacy compounding of human drugs.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges

Click here