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2012

Date

Title

February 1, 2012

FDA Clarifies Use of Product Names in Advertising and Promotional Labeling

Type: On the Subject

January 4, 2012

FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information

Type: On the Subject


2011

Date	Title
September 1, 2011	HHS Finalizes New Financial Conflicts of Interest Regulations Type: On the Subject
August 17, 2011	The IOM Report on Reform of the 510(k) Device Clearance Process and Beyond Type: On the Subject
July 27, 2011	HHS Proposes Overhaul of Human Subject Protections for Domestic Clinical Trials 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July 11, 2011	New FDA Draft Guidance Regarding Financial Disclosures by Clinical Investigators Type: White Papers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
May 11, 2011	Key Health Law Issues for 2011 Type: White Papers
May 6, 2011	Seventh Circuit Adopts “One Purpose Test” Under Federal Health Care Anti-Kickback Statute Type: On the Subject


2010

Date	Title
Winter 2010	International News, Issue 3, 2010 Type: International News
August 2, 2010	AAMC Task Force Releases New Guidance on Managing Conflicts of Interest in Clinical Care Type: White Papers
June 3, 2010	CMS Issues Interim Final Rule Affecting DMEPOS Suppliers and Laboratory, Imaging, Specialist and Home Health Providers Type: On the Subject
June 1, 2010	Qualifying Health-Sciences Companies Should Act Quickly to Secure Available Tax Credits and Grants for Investments in Therapeutic Discovery Projects 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
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 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 21, 2008	FDA Confirms Its View on Generic Drug Label Carve-Outs 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
July 14, 2008	DEA Issues Proposed Regulations for E-Prescribing of Controlled Substances Type: On the Subject
May 29, 2008	Merck Settles Vioxx® Litigation with State Attorneys General: an Analysis Type: White Papers
April 14, 2008	Third Circuit Decides Long-Awaited Antidepressant Drug Labeling Preemption Cases 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
February 19, 2008	FDA Releases Draft Guidance on Dissemination of Reprints of Peer Reviewed Journal Article 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
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
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


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

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