Maintaining and Verifying the Cold Chain
Tools and services provide thermal protection and prove cold-chain compliance.

Report from: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.

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The Expense of Vision in Outsourcing
Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.

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Tracking Quality in Drug Manufacturing-Video
Editorial Director Rita Peters offers a round up of recent enforcement actions from the FDA and other drug quality issues.

Regulatory and QA/QC Focus: Elemental Impurity Analysis
As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS). An upcoming Pharmaceutical Technology educational webcast will provide insight from leading industry experts on ICH, USP, and EMA guidelines for elemental impurity analysis and best practices and strategies to optimize the analytical workflow, data management, and data reporting when using ICP-MS.

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Preparing for Regulatory Inspections
Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). An upcoming Pharmaceutical Technology educational webcast on will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency to ensure successful inspections.

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Industry Needs to Drive the Dialogue Regarding FDA’s Quality Metrics Initiative
PDA's Quality Metrics Task Force weighs in on FDASIA and the use of quality metrics in the FDA Inspectional Risk Model.

Amarin Cuts Staff Following FDA Vote
Amarin cuts staff in half after an FDA committee rejects its product label expansion.

Novartis, Amgen, and Bristol-Myers Squibb Report Sales Up in Third Quarter
Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.

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SGS Life Science Services Opens Center of Excellence for Biophysical Analysis
SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

CDER Director Proposes Reclassification of Opioid Products
CDER recommends reclassifying opioid products as Schedule II.

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FDA Approves Extended-Release, Single-Entity Hydrocodone Product
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

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GSK, Gates Foundation Seek Heat-Stable Adjuvants for Vaccines
GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.

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