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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