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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 [email protected].
- 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
