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FDA - Related Content

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• GEN Articles

• Feature Articles: Orphan Drug Changes Brewing at the FDA
  Initiatives to De-Risk Drug Development Could Include Redesigning Clinical Trial Requirement
• Feature Articles: Navigating Electronic Submission Pathways
  Specialized Software and Document-Preparation Services Can Streamline Process
• Feature Articles: Oversight of Research Use Only Products
  RUO Assays and Instruments Face Greater Scrutiny
• Point of View: Tempering Regulation with Common Sense
  Regulators Need Appropriate Incentives and Disincentives
• Feature Articles: Expanded Access to Investigational Drugs
  New FDA Regulations Provide Effective Framework, but Questions Remain
• Point of View: Pharma Innovation in Critical Condition
  New Restrictions on Prescribing, Advertising, Distribution, and Sales Could Debilitate Industry
• Spotlight on the FDA: Cracking Down on Misinformation
  Agency Takes a Tough Stance on Hype, Defines Combinations, and Issues REMS Guidelines
• Spotlight on the FDA: Update on Evolving Regulatory Guidance
  Companies Need to Be Cognizant of and Continually Adjust to Changing Guidelines
• Spotlight on the FDA: Agency Gains Regulatory Clout
  Two Recent Actions that Amend Guidelines Illustrate Growth in Political Support
• Point of View: Activism, Mendacity, and Pathological Science
  Distortion of Science Has Given Rise to Flawed Policies and Regulations
• Spotlight on the FDA: Biosimilars and Follow-On Branded Biologics
  Regulatory Reflections on the Agency’s Expectations and Guidance for These Products
• Feature Articles: Banked-Specimen Retrospective Studies
  A Clinical Validation Shortcut or a Lengthy Detour?
• Point of View: Science and Technology Are Essential to Economic Recovery
  Regulation Must Be Scientifically Defensible and Risk-Based
• Regulatory Affairs: GEN's Spotlight on the FDA
  
• Regulatory Affairs: Spotlight on the FDA
  Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues
• Feature Articles: Making the Most of Pre-IDE Meetings
  With Proper Use these Get-Togethers Can Be Valuable Assets for IVD Companies
• Feature Articles: FDA Backs PAT to Help Solve Manufacturing Woes
  Process Analytical Technology Is a Key Part of Agency’s Plan for the 21st Century
• Feature Articles: FDA Seeks to Establish Branch Office in China
  Will It Truly Overcome Safety Concerns or Is It Just Window Dressing?
• Feature Articles: Paucity of Biopharma Approvals Raises Alarm
  Lower Numbers, Novelty, and Economic Impact Indicate Problems
• Point of View: “MAP” for Improving Drug Testing
  Mandatory Alternatives Petition Urges FDA to Require Use of Replacements to Animal Testing

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