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2008

Date	Title
November 3, 2008	Developments in Medicare Payment for Services in Clinical Trials Type: On the Subject
September 16, 2008	Top 10 Intellectual Property and Regulatory Legal Issues for Biotech Start-Ups Type: On the Subject
April 29, 2008	FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions Type: On the Subject
February 28, 2008	AAMC/AAU Joint Advisory Committee Issues New Guidelines on Managing Conflicts of Interest Type: On the Subject
February 21, 2008	Ownership of Biological Samples and Clinical Data II: U.S. Supreme Court Denies Certiorari in the Catalona Decision Type: On the Subject


2007

Date	Title
October 15, 2007	FDA Oversight of Clinical Trials Type: On the Subject
July 11, 2007	CMS final decision on reconsideration of the Clinical Trials NCD: Maintains status quo. Type: On the Subject
May 31, 2007	May 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators Type: On the Subject

Date

Title

October 15, 2007

FDA Oversight of Clinical Trials

Type: On the Subject

July 11, 2007

CMS final decision on reconsideration of the Clinical Trials NCD: Maintains status quo.

Type: On the Subject

May 31, 2007

May 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators

Type: On the Subject


2006

Date	Title
July 25, 2006	CMS Announces Reconsideration of Clinical Trial Billing Policy Type: On the Subject
May 1, 2006	Ownership of Biological Samples and Clinical Data: Catalona Decision Announced Type: On the Subject

Date

Title

July 25, 2006

CMS Announces Reconsideration of Clinical Trial Billing Policy

Type: On the Subject

May 1, 2006

Ownership of Biological Samples and Clinical Data: Catalona Decision Announced

Type: On the Subject


2005

Date	Title
September 30, 2005	U.S. Congress Announces New Investigations into University Spending on Clinical Research Type: On the Subject
August 11, 2005	New Federal Requirements for Investigating and Managing Allegations of Research Misconduct Type: On the Subject

Date

Title

September 30, 2005

U.S. Congress Announces New Investigations into University Spending on Clinical Research

Type: On the Subject

August 11, 2005

New Federal Requirements for Investigating and Managing Allegations of Research Misconduct

Type: On the Subject


2004

Date	Title
November 4, 2004	Increasing FDA Oversight Over Clinical Research Type: On the Subject
April 28, 2004	Law of Tissue Banks and Stem Cells in Flux Type: On the Subject
April 7, 2004	Massachusetts Appeals Court Decision Casts Doubt on the Tax-Exempt Status of Hospital Affiliated Medical Practices Type: On the Subject

Date

Title

November 4, 2004

Increasing FDA Oversight Over Clinical Research

Type: On the Subject

April 28, 2004

Law of Tissue Banks and Stem Cells in Flux

Type: On the Subject

April 7, 2004

Massachusetts Appeals Court Decision Casts Doubt on the Tax-Exempt Status of Hospital Affiliated Medical Practices

Type: On the Subject

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Our Newsletters

2008

Developments in Medicare Payment for Services in Clinical Trials

Top 10 Intellectual Property and Regulatory Legal Issues for Biotech Start-Ups

FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions

AAMC/AAU Joint Advisory Committee Issues New Guidelines on Managing Conflicts of Interest

Ownership of Biological Samples and Clinical Data II: U.S. Supreme Court Denies Certiorari in the Catalona Decision

2007

FDA Oversight of Clinical Trials

CMS final decision on reconsideration of the Clinical Trials NCD: Maintains status quo.

May 2007 FDA Draft Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects—Supervisory Responsibilities of Investigators

2006

CMS Announces Reconsideration of Clinical Trial Billing Policy

Ownership of Biological Samples and Clinical Data: Catalona Decision Announced

2005

U.S. Congress Announces New Investigations into University Spending on Clinical Research

New Federal Requirements for Investigating and Managing Allegations of Research Misconduct

2004

Increasing FDA Oversight Over Clinical Research

Law of Tissue Banks and Stem Cells in Flux

Massachusetts Appeals Court Decision Casts Doubt on the Tax-Exempt Status of Hospital Affiliated Medical Practices

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