Recent confusion and ongoing actions related to the FDA’s Inactive Ingredient Database (IID) - What should be included in the ANDA?
The FDA's inactive ingredient database (IID) does not currently provide information on the maximum allowable amount of excipient per day or per dosage form. This had led to significant confusion among generic drug manufacturers, with excipient amounts chosen not from the standpoint of the most...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
International Pharmaceutical Excipients Council
2016-10-01
|
| Series: | Journal of Excipients and Food Chemicals |
| Online Access: | https://jefc.scholasticahq.com/article/924-recent-confusion-and-ongoing-actions-related-to-the-fda-s-inactive-ingredient-database-iid-what-should-be-included-in-the-anda |
| Summary: | The FDA's inactive ingredient database (IID) does not currently provide information on the maximum allowable amount of excipient per day or per dosage form. This had led to significant confusion among generic drug manufacturers, with excipient amounts chosen not from the standpoint of the most effective formulation, but rather, from the standpoint of the safest approvable route. The IID needs to be modernized to remove ambiguous detrimental constraints on incorporating the optimum amounts of excipients in generic formulations. |
|---|---|
| ISSN: | 2150-2668 |