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Free Articles
Following are recent articles on pharma and regulatory topics by FDAMap experts. If there are any particular topics/areas that you would like more information on, please email us at info@fdamap.com.


  • The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway
  • Resolving Scientific Disputes  with FDA: Regulatory Processes  and Practical Tip
  • The Promise of Biogenerics: Hope and Hype
  • Biosimilars:  Past, Present  and Future
  • Developing Botanical Products from India  for the  US Market
  • Energizing Innovation
  • An FDA Audit Is Good for You
  • Forecasting for Success: The Power of Regulatory Gap Analysis
  • Generics Industry Becoming More Competitive and Profit Margins Shrinking
  • Designing a Global Product Development Strategy
  • Strategies for Implementing the New GMPs for Dietary Supplement
  • ​Global Development of an Innovative  Medical Device for the US Market
  • Meeting With FDA Can Increase  the Probability of Product Approval
  • Risks and Benefits of Conducting Preclinical Studies in the Global Setting
  • Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms
  • Small Business–Big Opportunities
  • SOPs: Least Understood, Most Important Tool  to Ensure Regulatory Compliance
  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval
  • Developing Traditional  Chinese Medicines as  Botanical Drugs for the US Market​
  • SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance
  • Meeting With FDA Can Increase the Probability of Product Approval 
  • Energizing Innovation

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