Bing Li of the FDA’s Division of Bioequivalence
At the recent Orlando Inhalation Conference, Bing Li of the FDA’s Division of Bioequivalence in the Office of Generic Drugs (OGD) of the Center for Drug Evaluation and Research (CDER) provided a list of frequently asked questions about Abbreviated New Drug Applications (ANDAs) for nasal sprays along with her answers.
This is the second of two articles based on Bing Li’s talk. For the first article, which provides practical advice for nasal spray ANDAs, click here.
Nasal Spray ANDA FAQs
Q: How many retention samples should be reserved for each site of in vivo and in vitro bioequivalence (BE) studies?
A: If the BE studies are conducted at one site, then at least 50 units for each batch of test and reference products, including placebos if applicable, must be retained.
If the BE studies are conducted at multiple sites, then at least 10 units per each batch per site and a total of least 50 units total for each batch of test and reference products, including placebos, must be retained.
For example: if a BE study is conducted at 6 sites, using 1 batch of test drug (T) and 1 batch of reference drug (R), the total number of reserve samples to be retained for T and R must be at least 60, with at least 10 units per each batch per site.
Please refer to the Drug Specific BE Guidance for Budesonide Inhalation Suspension for details
Q: What are FDA’s expectations for plume height?
A: Currently, plume height data is submitted as supporting evidence only. FDA does not set specific criteria for plume height evaluation.
On the next page: more FAQs
