FDA Supac guidance for ER [Regulatives / Guidelines]
Hi,
Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings?
Thanks
John
Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings?
Thanks
John
Complete thread:
- FDA Supac guidance for ERjag009 2018-09-07 20:31 [Regulatives / Guidelines]
- FDA Supac guidance for ER Helmut 2018-09-09 14:04
- FDA Supac guidance for ER jag009 2018-09-10 18:38
- FDA Supac guidance for ER Helmut 2018-09-09 14:04