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2012

Date	Title
January 4, 2012	FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information Type: On the Subject

Date

Title

January 4, 2012

FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information

Type: On the Subject


2011

Date	Title
September 16, 2011	Medical Devices: An Introduction to the Regulatory Regime in China and Options for Foreign Investors in the Medical Device Sector Type: China Law Alert
September 1, 2011	HHS Finalizes New Financial Conflicts of Interest Regulations Type: On the Subject
July 27, 2011	HHS Proposes Overhaul of Human Subject Protections for Domestic Clinical Trials Type: On the Subject
July 25, 2011	Procedures and Licensing for the Establishment of Life Sciences Companies in China Type: On the Subject
July 11, 2011	New FDA Draft Guidance Regarding Financial Disclosures by Clinical Investigators Type: White Papers
July 7, 2011	OHRP Revises Federalwide Assurance Type: On the Subject
1 July 2011	2010 Bribery Act: Commercial Applicability Type: On the Subject
June 23, 2011	FTC Hosts Workshop on Preventing Patent “Hold-Ups” in Standard-Setting Type: On the Subject


2010

Date	Title
July 27, 2010	OCR Issues Proposed Modifications to HIPAA Privacy and Security Rules to Implement HITECH Act Type: White Papers
May 5, 2010	Health Care Reform: Congress Creates Independent Payment Advisory Board: Are Medicare Solvency Decisions Finally on the Way? Type: On the Subject
April 19, 2010	Clarification of Data Controller and Data Processor under EU Privacy Directive – New Opinion of Article 29 Data Protection Working Party Type: On the Subject
April 12, 2010	Health Care Reform: Substantial Fraud and Abuse and Program Integrity Measures Enacted Type: White Papers
March 30, 2010	District Court Strikes Down Gene Patents and Methods of Using Genes as Unpatentable Subject Matter Type: On the Subject
March 9, 2010	FDA Proposes New Regulation to Require Sponsors to Report Suspected Data Falsification Type: On the Subject


2009

Date	Title
August 27, 2009	Regulatory Update: HITECH’s HHS and FTC Security Breach Notification Requirements Type: White Papers
August 20, 2009	EMEA and FDA Focus on Clinical Research Safety and Enforcement Type: On the Subject
July 24, 2009	Federal Law Requires Businesses to Implement Formal Identity Theft Prevention Programs Type: On the Subject
May 28, 2009	Massachusetts Enacts Final Rules Governing Pharmaceutical and Medical Device Manufacturer Conduct Type: White Papers
April 30, 2009	FTC Issues Advisory Opinion Approving Clinical Integration Program Type: White Papers
April 13, 2009	The SAFETY Act – How It Affects Your Business Type: On the Subject
March 13, 2009	Massachusetts Approves Regulations to Implement the Pharmaceutical and Medical Device Disclosure Law Type: On the Subject
February 26, 2009	Opinions on Strengthening the Centralised Procurement of Drugs by Medical Institutions Type: China Law Alert
February 20, 2009	Economic Stimulus Package: Policy Implications of the Financial Incentives to Promote Health IT and New Privacy Type: White Papers
February 9, 2009	New FDA Guidance on Adverse Event Reporting to the IRB Type: On the Subject
January 29, 2009	Top Nine Health Law Issues for 2009 Type: On the Subject
January 21, 2009	Early Government Enforcement and Oversight Activity Promises a Challenging 2009 Type: On the Subject
January 9, 2009	AdvaMed Adopts Revised Code of Ethics on Interactions with Health Care Professionals Type: On the Subject
January 9, 2009	Massachusetts Proposes Regulations for Pharmaceutical and Medical Device Disclosure Law Compliance Type: White Papers


2008

Date	Title
December 19, 2008	Massachusetts Releases Draft Applications for Life Sciences Certification, Tax Incentive Participation Type: On the Subject
November 3, 2008	Developments in Medicare Payment for Services in Clinical Trials Type: On the Subject
October 1, 2008	FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis Type: On the Subject
September 16, 2008	Top 10 Intellectual Property and Regulatory Legal Issues for Biotech Start-Ups Type: On the Subject
August 19, 2008	Massachusetts Enacts Pharmaceutical and Medical Device Disclosure Law Type: White Papers
July 15, 2008	PhRMA Revises Code on Interactions with Healthcare Professionals Type: White Papers
June 18, 2008	Massachusetts Enacts Comprehensive $1 Billion Life Sciences Initiative Type: On the Subject
May 29, 2008	Merck Settles Vioxx® Litigation with State Attorneys General: an Analysis Type: White Papers
April 29, 2008	FDA Issues Draft Guidance on Certification Requirements Under New Clinical Trial Registration and Posting Provisions Type: On the Subject
April 14, 2008	Third Circuit Decides Long-Awaited Antidepressant Drug Labeling Preemption Cases Type: On the Subject
February 28, 2008	Supreme Court Holds That FDA Premarket Approval of Class III Medical Device Preempts State Tort Law 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
July 2007	International News, Issue 2, 2007 Type: International News
April 2007	International News, Issue 1, 2007 Type: International News


2006

Date	Title
November 2006	Monetizing Medical Device Research Type: White Papers
September 2006	International News, Issue 2, 2006 Type: International News
May 1, 2006	Ownership of Biological Samples and Clinical Data: Catalona Decision Announced Type: On the Subject

Date

Title

November 2006

Monetizing Medical Device Research

Type: White Papers

September 2006

International News, Issue 2, 2006

Type: International News

May 1, 2006

Ownership of Biological Samples and Clinical Data: Catalona Decision Announced

Type: On the Subject


2005

Date	Title
November 2005	IP Update, Vol. 8, No. 11, November 2005 Type: IP Update
October 2005	IP Update, Vol. 8, No. 10, October 2005 Type: IP Update
October 14, 2005	Brussels Brief - October 14, 2005 Type: Brussels Brief
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
June 3, 2005	Brussels Brief - June 3, 2005 Type: Brussels Brief
April 29, 2005	Brussels Brief - April 29, 2005 Type: Brussels Brief
April 22, 2005	Brussels Brief - April 22, 2005 Type: Brussels Brief
April 15, 2005	Brussels Brief - April 15, 2005 Type: Brussels Brief
April 8, 2005	Brussels Brief - April 8, 2005 Type: Brussels Brief
March 7, 2005	Health: Key Issues Under Medicare’s Final Prescription Drug Rule Type: On the Subject


2004

Date	Title
September 2004	IP Update, Volume 7, No. 9, September 2004 Type: IP Update
September 22, 2004	CMS Proposes Rule on Medicare’s New Drug Benefit Type: On the Subject
Winter 2004	International News Winter 2004 Type: International News

Date

Title

September 2004

IP Update, Volume 7, No. 9, September 2004

Type: IP Update

September 22, 2004

CMS Proposes Rule on Medicare’s New Drug Benefit

Type: On the Subject

Winter 2004

International News Winter 2004

Type: International News


2003

Date	Title
December 2003	IP Update, Vol. 6, No. 12, December 2003 Type: IP Update
October 2003	IP Update, Vol. 6, No. 10, October 2003 Type: IP Update
January 2003	IP Update, Volume 6, No. 1, January 2003 Type: IP Update

Date

Title

December 2003

IP Update, Vol. 6, No. 12, December 2003

Type: IP Update

October 2003

IP Update, Vol. 6, No. 10, October 2003

Type: IP Update

January 2003

IP Update, Volume 6, No. 1, January 2003

Type: IP Update


2000

Date	Title
November 2000	Massachusetts Prohibits Genetic Testing Discrimination Type: On the Subject

Date

Title

November 2000

Massachusetts Prohibits Genetic Testing Discrimination

Type: On the Subject

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