What's Next in: Strategy and Regulation - Pharmaceutical Technology

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What's Next in: Strategy and Regulation


Pharmaceutical Technology


The development of harmonized international standards for drugs and biologics has been an important undertaking for the last decade. These initiatives will continue to play a central role in ensuring drug product quality on a global basis. FDA also is working with other regulatory authorities to explore new models for accepting inspection findings from local agencies that can, in some cases, reduce the need for US inspectors to travel overseas. Although some policymakers will object to reduced direct oversight of medical products manufactured overseas for US consumers, FDA's limited resources will necessitate the increased reliance on capable foreign regulators to support US oversight of global pharmaceutical production.

Jill Wechsler, Washington editor,
Pharmaceutical Technology

Industry experts give their predictions for the next 30 years. Read Editor-in-Chief Michelle Hoffman's introduction here. See what's next in:

Strategy and Regulation
Outsourcing
Solid-Dosage Formulation
Ingredients
Drug Delivery
Packaging
Analytical Testing
Information Technology


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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 LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
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