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 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
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
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