Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Inside Standards
Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
February 2, 2014
PDA works with FDA to create pharmaceutical quality metrics.
Deficiencies Found in API Inspections
December 2, 2013
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Control of Elemental Impurities
November 2, 2013
The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.
USP Partners Globally for 21st-Century Medicines
July 2, 2013
USP focuses on building worldwide partnerships in standards-setting activities.
Moisture Permeation of Pharmaceutical Packaging
April 2, 2013
USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.
Whitepapers
Introduction to cGMP Sampling: The Basics
Education versus Training
Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider
505(b)(2): Fast and Cost-Effective Drug Approval
Outsourcing: A Rapid, Cost-Effective Option for Electronic Submissions
FDA approves Ragwitek for short ragweed pollen allergies
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
Puerto Rico bakery agrees to stop manufacturing and distributing products
FDA approves Tanzeum to treat type 2 diabetes
FDA approves expanded indication for certain pacemakers and defibrillators

Last updated on Thu Apr 17 14:32:00 EDT 2014

Standards & Regulations
Seeking Harmonization in Nanomedicines Regulatory Framework
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Generic Drugs Face Regulatory and Scientific Challenges
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Regulatory Roundup
Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.
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