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Regulatory Update | 21 May 2012

Brazil: Anivsa Sets Confidentiality Criteria

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A notice (Ordinance No. 748-B/2012) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access [Read More...]

Tags: Access to Information Law Anvisa FOIA Freedom of Information Information Transparency
Regulatory Update | 21 May 2012

Brazil: Anivsa Implements Freedom of Information Law

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Greater transparency is an integral part of the reorganization of Brazil’s national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its [Read More...]

Tags: Access to Information Law Anvisa FOIA Freedom of Information Information Transparency
Latest News | 2 May 2012

FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

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Months after the British Medical Journal (BMJ) reported that the US Food and Drug Administration’s (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial [Read More...]

Tags: BMJ Clinical Trials ethics FDA NIH Published Studies Study Transparency Warning
Latest News | 19 April 2012

Legislation to Make FDA’s Regulatory Calculus More Transparent Introduced in Congress

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Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) introduced legislation that would reform the US Food and Drug Administration’s (FDA) regulatory transparency by mandating the agency submit to Congress [Read More...]

Tags: Act Bill Burr Coburn Congress FDA Legislation PATIENTS FDA Act Regulatory Senate Transparency
Latest News | 6 February 2012

Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements

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A bill introduced in the US House of Representatives by Reps. Ben Quayle (R-AZ), Dennis Ross (R-FL) and Howard Coble (R-CA) would place “limitations on consent decrees and settlement agreements by [Read More...]

Tags: Coble Consent Decree Consent Decrees FDA H.R. 3862 House Judiciary Committee Quayle Ross Settlement Agreements Transparency
Latest News | 4 January 2012

BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

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A series of studies published this week in the British Medical Journal by groups of researchers from various universities have found serious lapses in clinical trial reporting and transparency.Among [Read More...]

Tags: BMJ Clinical Trials ethics NIH Published Studies Study Transparency