Thanks for asking this. There are couple of ways to market drug in US other than NDA and ANDA. For example, 1. OTC monograph Process: To bring non-prescription drugs into the market which are not approved under the section 505 of the FD&C Act. This has to follow Section 505G of the FD&C Act. 2. Biologics Licence Application (BLA): For Biologics drug products. These informations are available in Purple Book. 3. New Animal Drug Application (NADA)/ Abbreviated New Animal Drug Application (ANADA): To bring Animal drugs in to the US martket. These informations are avaliable in Green book.
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Very well explained!
very informative and well explained
Thank you 🙏
Thank you for the informative video!
Very informative ..Keep posting
What are the other ways to market drug in US other than NDA and ANDA?
Thanks for asking this. There are couple of ways to market drug in US other than NDA and ANDA.
For example,
1. OTC monograph Process: To bring non-prescription drugs into the market which are not approved under the section 505 of the FD&C Act. This has to follow Section 505G of the FD&C Act.
2. Biologics Licence Application (BLA): For Biologics drug products. These informations are available in Purple Book.
3. New Animal Drug Application (NADA)/ Abbreviated New Animal Drug Application (ANADA): To bring Animal drugs in to the US martket. These informations are avaliable in Green book.
Dear please explain reference std and reference listed drugs in hindi