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
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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