- What is a market withdrawal?
- A market withdrawal is similar to a recall except the violation is minimal and poses very little or no risk to the public. For example, a company uses an incorrect label although the information is correct. FDA would consider this a market withdrawal because it poses no safety threat. FDA does not monitor market withdrawals.
- Is there any way a regulatory authority can contact FDA to verify the authenticity of a certificate?
- The certificates given to the companies are very specific. They are stamped, numbered and have an embossed seal with a specific ribbon on watermarked paper.
- Are there any regulations with regard to the timeframe between approval of a drug and its availability in the U.S. market?
- Once a company has a letter of approval, they can ship the product to the importing country.
Lesson status: Incomplete (0% done)
Topic: page 6 of 8 (Lesson: page 32 of 35)