|Articles|August 15, 2002

BioPharm International

  • BioPharm International-08-01-2002
  • Volume 15
  • Issue 8

Inside Washington: User Fee Program Seeks to Spur Biotech Development

Author(s)Jill Wechsler

PDUFA III boost manufacturer fees to cover postapproval surveillance and streamline the FDA review process
To view a PDF of this article from the BioPharm International archives, click this link

Articles in this issue

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Guest Editorial: Quality Agreements with Contract Laboratories

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Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

over 23 years ago

Virus Inactivation in the 1990s ? and into the 21st Century: Part 2, Red Blood Cells and Platelets

over 23 years ago

Making Regulatory Compliance a Core Process: Director and Officer Liability Exposure

over 23 years ago

Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issue

over 23 years ago

Your Vested Interests: Gorillas In Our Midst

over 23 years ago

Outsourcing Outlook: How to Engage in a Strategic Outsourcing Relationship

over 23 years ago

Throughput Analysis and Debottlenecking of Biomanufacturing Facilities ? A Job for Process Simulators

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