Business center
Post trade leads
Rank promotion
You are at: Home » News » International »

FDA issues Final Guidance on Considerations in Demonstrating Interchangeability with a Reference Pro

Increase font size  Decrease font size Date:2019-05-16   Views:42

The U.S. Food and Drug Administration (FDA) issued final guidance for industry "Considerations in Demonstrating Interchangeability With a Reference Product” and announced the release in an FDA statement. This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act).

[ Search ]  [ ]  [ Email ]  [ Print ]  [ Close ]  [ Top ]

Total:0comment(s) [View All]  Related comment

Home | About | Service | copyright | agreement | contact | about | SiteMap | Links | GuestBook | Ads service | 京ICP 68975478-1
Tel:+86-10-68645975           Fax:+86-10-68645973
E-mail:yaoshang68@163.com     QQ:1483838028