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Q: Do clinical trials ever go wrong?

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A test to check for cancer of the cervix, the opening to a woman's womb. It is done by removing cells from the cervix. The cells are then prepared so they can be seen under a microscope.

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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
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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
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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US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 14:07:46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 :FDA's proposed rule on Post-marketing Safety Reporting for Combination.. 2010-01-12 12:15:13 
GCP HelpDesk
Joined: 2009-06-18 15:31:58
Posts: 62
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,
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