Search

Home > New FDA Approvals > 014 - FDA Releases Drug-Specific Guidance Documents; Celgene's mongersen for Crohn's disease in REVOLVE: disappointing data; Updated FDA Manual Offers Inside Look at Inspection Protocols
Podcast: New FDA Approvals
Episode:

014 - FDA Releases Drug-Specific Guidance Documents; Celgene's mongersen for Crohn's disease in REVOLVE: disappointing data; Updated FDA Manual Offers Inside Look at Inspection Protocols
Category: Science & Medicine
Duration: 0
Publish Date: 2017-10-20 06:00:00
Description:

0:44 FDA releases several new, revised drug-specific guidance documents

http://raps.org/Regulatory-Focus/News/2017/10/19/28717/FDA-Releases-Flurry-of-New-Revised-Drug-Specific-Guidance-Documents/

In an effort to provide support for abbreviated new drug applications, the FDA on Thursday issued a flurry of product-specific recommendations, providing guidance for companies looking to develop generic versions of a number of popular medicines. 

1:23 https://www.forbes.com/sites/matthewherper/2017/10/19/drug-celgene-bought-for-710-million-fails/#69d15ae42377

Celgene announced that after consulting the data safety and monitoring committee that was overseeing the main mongersen study, called REVOLVE, it had decided to stop developing the drug.

2:39 Updated FDA Manual Offers Inside Look at Inspection Protocols

http://www.raps.org/Regulatory-Focus/News/2017/10/18/28712/Updated-FDA-Manual-Offers-Inside-Look-at-Inspection-Protocols/

Need medical writing help? info@nascentmc.com
Total Play: 0