Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Inside Standards
Securing the Supply Chain
July 2, 2014
Regulators and industry leaders take on the task of securing the drug supply chain.
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.
Whitepapers
505(b)(2): Fast and Cost-Effective Drug Approval
Outsourcing: A Rapid, Cost-Effective Option for Electronic Submissions
Preparing for Mandatory Electronic Submission of Drug Establishment Registration and Drug Listing Information
Tablet Pro
Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging
FDA takes enforcement action against Michigan sandwich company
FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
FDA approves new treatment for rare form of hemophilia

Last updated on Fri Nov 21 15:32:00 EST 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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