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FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
Click here