Follow us on




Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

 Forums
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
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 01:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-20 19:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-18 23:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-18 22:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 07:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-04 20:52:16
CONSORT III (2010)   by  on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 12:12:14
 Subject :US FDA Warning Letters in Clinical Investigation for the Month of Dece.. 2009-12-31 09:10:00 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location
Subject :US FDA Warning Letters in Clinical Investigation for the Month of December 2009

Dear Friends,

Please find attached US FDA warning letter for the month of December 2009.

Thanks and regards,



Attachments
 December 2009.pdf [25 KB] ::
IP Logged
GCP HelpDesk
Page # 


Powered by ccBoard