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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.
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EFGCP–EUCROF Joint Workshop Final Report   by GCP HelpDesk on 2010-08-20 20:12:20
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by GCP HelpDesk on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by GCP HelpDesk on 2010-06-13 18:07:59
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by GCP HelpDesk on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by GCP HelpDesk on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by GCP HelpDesk on 2010-05-01 09:40:32
Major developments in EU Clinical Trial Guidances   by GCP HelpDesk on 2010-04-21 03:10:55
CONSORT III (2010)   by GCP HelpDesk on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by GCP HelpDesk on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by GCP HelpDesk on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by GCP HelpDesk on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by GCP HelpDesk on 2010-02-06 20:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by GCP HelpDesk on 2010-01-27 19:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by GCP HelpDesk on 2010-01-22 18:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by GCP HelpDesk on 2010-01-21 19:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by GCP HelpDesk on 2010-01-14 04:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by GCP HelpDesk on 2010-01-12 20:15:13
EMEA Guidelines on Cystic Fibrosis Drug Development   by GCP HelpDesk on 2010-01-05 17:14:16
US-FDA' proposed rule on Informed Consent regulations   by GCP HelpDesk on 2010-01-03 06:22:47
International Compilation of Human Research Protections 2010 Edition   by GCP HelpDesk on 2009-12-23 22:59:39
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by GCP HelpDesk on 2009-12-18 03:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by GCP HelpDesk on 2009-12-05 02:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by GCP HelpDesk on 2009-11-30 18:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by GCP HelpDesk on 2009-11-21 15:57:50
Companies to Disclose All Clinical Trials in Patients   by GCP HelpDesk on 2009-11-19 17:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by GCP HelpDesk on 2009-11-09 17:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by GCP HelpDesk on 2009-11-09 06:28:30
PhRMA's New Clinical Trial Guidelines   by GCP HelpDesk on 2009-10-05 18:21:30
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 Ethics, GCP, Quality Assurance and Regulatory Affairs
Topics Replies Views Last Post
EMEA Revised Q and A document
by GCP HelpDesk on 2009-09-01 21:57:52 		0 2327 by GCP HelpDesk
on 2009-09-01 21:57:52
Interpretation of " Relevant Correspondence " in ICH GCP 8.3.11
by GCP HelpDesk on 2009-07-13 20:26:24 		0 2781 by GCP HelpDesk
on 2009-09-01 21:47:23
FAQs on US-FDA IRB registration
by GCP HelpDesk on 2009-08-07 02:14:03 		0 2298 by GCP HelpDesk
on 2009-09-01 21:47:09
US-FDA Guidance for Industry: Drug Induced Liver Injury: Premarketing Clinical Evaluation
by GCP HelpDesk on 2009-08-10 22:59:53 		0 1957 by GCP HelpDesk
on 2009-09-01 21:46:52
Final Rules for Expanded Access to Investigational Drugs for Treatment Use
by Rajashekharam on 2009-08-14 19:17:08 		0 2045 by Rajashekharam
on 2009-08-14 19:17:08
Prcoedural Advice and FAQs on PIPs
by Harrison on 2009-07-24 17:53:09 		0 2290 by Harrison
on 2009-07-24 17:53:09
FDA Draft Guidance on Post-Marketing CTs
by Leon on 2009-07-24 17:46:42 		0 2172 by Leon
on 2009-07-24 17:46:42
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