ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 17, 2013 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 17, 2013
News
Hameln Pharmaceuticals Receives FDA Warning Letter
By Stephanie Sutton
FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing "significant" cGMP violations for finished pharmaceuticals at the company?s facility in Hameln, Germany.
Lonza Expands Antibody-Drug Conjugate Manufacturing Capacity
By Amy Ritter
Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland.
FDA Releases Guidance on Opioids
By Susan Haigney
FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance
EMA Updates Guideline for Anticancer Medicines
By Stephanie Sutton
The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.
Industry Briefs: January 14, 2013
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

ADVERTISEMENT

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
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
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
Click here