The FDA and industry has done an excellent job in identifying and reducing Medical Product Shortages. Please update yourself by reading the information on FDA's website under CDER/Drug Shortages. We need to find solutions (not more reasons) for the shortages.
Project one: One of the most important shortages is for sterile injectable oncology drugs (medically necessary drugs) particularly manufactured by generic companies. In the next few days, I will post thoughts, comments, questions for your input so we can arrive at a faster solution.
Initially, I do not see answers to:
1. What are the specific quality issues?
2. A list of FDA guidances that can be used to resolve this situation.
2. Who are the partners that will solve the problem
3. What is the win-win solution?
4. Create better incentives (other than saving lives)