*** Need an answer to your GCP query ? Post your query at HelpDesk ***
Follow us on
Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
 Forums
Board Index Latest Posts Welcome Guest   [Register]  [Login]
EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
 Subject :FDA's proposed rule on Post-marketing Safety Reporting for Combination.. 2010-01-12 12:15:13 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Subject :FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts

Dear Friends,

Closing date for the comments on the FDA's proposed rule on Post-marketing Safety Reporting for Combination Products is January 29, 2010 and seeking comments on its proposed rule to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products.  The proposed rule is intended to clarify the reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product.

Click here for the proposed rule.

Kind regards,
IP Logged
GCP HelpDesk
Page # 


Powered by ccBoard