Hyman Phelps and McNamara Hyman Phelps and McNamara
Developments in the Law
  FDA Announces Intention to Regulate LDTs as Devices  August 7, 2014
  Significant Settlements, Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014  January 2014
  How to Effectively Use FDA's Presubmission Process  May 12, 2014
  4 Regulatory Challenges Facing IVD Companies Today  May 12, 2014
  FDA and LDTs  April 9, 2014
  Examining Hot Button Areas for FDA & Related Government Enforcement  February 12, 2014
  The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?  February 4, 2014
  Application of Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices  January 5, 2014
  Thomson Reuters Book: Commercialisation of Health Care  November 4, 2013
  Trends in Personalized Medicine  October 2013
  The Long and Winding Road to FDA Regulation of LDTs  October 2013
  What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions  September 2, 2013
  Draft Guidance on Medical Device Recalls: Improvements Are Needed  July / August 2013
  How, and When, Will FDA Regulate LDTs?  July 15, 2013
  New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked  April 22, 2013
  The US FDA and its Draft Guidance on Medical Device Appeals  April 2013
  Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations  February 2013
  Summary of CMS Final Rule on Transparency Reporting  February 12, 2013
  Real-World Implications of United States v. Caronia  January 31, 2013
  Should DEA Provide Guidance & Conduct Rulemaking on Suspicious Orders to Ensure Balanced Approach to Reduce Abuse & Ensure Avail. of Needed Medicine?  January, 2013
  FDASIA's Impact on Novel IVDs  October 1, 2012
  Ten Short Tips For The Medical Device Industry  September / October 2012
  USP Recognizes Work of Food Ingredients Expert Committee  September 2012
  US FDA should be required to provide 510(k) decision summaries for devices - a missed opportunity by lawmakers  July 2012
  Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools  June 20, 2012
  A Year in Review: CDRH Draft Guidance Documents of 2011  May / June 2012
  CMS proposed ACA rule - 2-4-2012  April 2012
  Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad  April 2012
  FDA Appeals - Improving Your Odds of Success: Trends, Expectations, Strategies  March 21, 2012
  Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs  March 2012
  Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center  January 2012
  Recent Developments in Food and Drug Law  January 2012
  CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment Interests  December 22, 2011
  Court Ruling Casts Doubt On FDA's Use Of Guidance Documents  December 16, 2011
  HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent  December 2011
  Death, Taxes and DEA Inspections: Dealing with the Inevitable  November/December 2011
  Knocking On Your Front Door: Government Visits To Employees' Homes  August 19, 2011
  FDA's Pursuit of Punishing People  July / August 2011
  New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers -
More 510(k)s
 August 2011
  Draft Guidance for RUO Products Issued  August 1, 2011
  Security Dividend: What the U.S. can obtain from investing in international health capacity  June 2011
  Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New Technology  May 2011
  Personalized Medicine: Improving the Regulatory Pathway  May 2011
  Just What the Doctor Ordered? Legal Implications of Scheduling and Prescription-Only Approach to Methamphetamine Precursor Regulation  May 2011
  Guidance for Industry Helps FDA (Mostly) Win First Amendment Case on Health Claims  May 2011
  Uncertainty Persists with RUO Products - FDA May Be Considering More Restrictive Approach with Research Use Only Assays  April 1, 2011
  Lessons from Jamkhed to Cleveland: In Health Care Cost Reduction, India: 1, U.S.: 0  Spring 2011
  D.I.Y. Enforcement: Relators, the False Claims Act and the FDCA  January/February 2011
  What Happens to Medical Device Reports Once They Reach FDA?  January 2011
  Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products  January 2011
  Must FDA Treat Similarly-Situated Competitors the Same Way?  December 2010
  On FDA And Food Ingredient Safety: Is The "Gras" Henhouse At Risk?  December 3, 2010
  When Will the Next Five Billion People Get A Turn?  December 2010
  The Cost of Inadequate Substantiation  November 5, 2010
  The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine  October 8, 2010
  New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment  September / October 2010
  Publish and Perish: A Disturbing Trend in the European Union's Regulation of Nutrition Health Claims Made on Foods  September / October 2010
  Regulating Laboratory-Developed Tests  September 15, 2010
  Using Social Media in FDA-Regulated Industries: The Essential Guide  September 2010
  The FTC's New Take on Health-Related Advertising: What Companies Facing FTC Enforcement Need to Know  September / October 2010
  15th Anniversary Essay: Regulation Then and Now  August 2010
  Advertising and Promotion: FDA Is Not the Only Cop on the Beat  August 2010
  The Problem of Regulatory Uncertainty  July 2010
  Whistleblowers: Treat Them With Kid Gloves  July 2010
  Regulatory Pathways for Clearance or Approval of IVDs  May 2010
  The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?  April 2010
  Oversight of Research Use Only Products  March 1, 2010
  In the Name of Graduate Medical Education: What Mount Sinai Medical Center's FICA Tax Victory Means for Today's Teaching Hospitals  February 2010
  Court Empowers Qui Tam Defendants To Sue Third Parties For Indemnification  February 26, 2010
  But My Lawyer Told Me It Was Okay  January/February 2010
  Ingredient Testing for Food and Supplement Advertising Claims: Keeping Up with an Evolving Standard  October 2010
  In Vitro Diagnostic Tests for Cancer: Regulation of Laboratory Developed Tests  January 2010
  Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act  November/December 2009
  Trends in FDA's Use of Class-Wide REMS  December 2009
  The Family Smoking Prevention and Tobacco Control Act: An Overview  December 2009
  Beating the Heat: What Food & Supplement Marketers Need to Know About the FTC's Summer of Litigation  October 2009
  Contracting with the Dietary Supplement cGMPs in Mind  September 2009
  The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?  September/October 2009
  Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine  September 2009
  The Custom Device Exemption: What Is It And Does It Ever Apply?  September 2009
  Vindicated on Appeal - It Does Happen  July/August 2009
  Banked-Specimen Retrospective Studies  June 15, 2009
  Search Warrants - What Happens When the FDA Storm Arrives  May/June 2009
  Seeing Red Over "Green" - The Fight Over "Organic", "Natural", and "Sustainable"  May 2009
  Dermatologic Therapy  May 9, 2009
  The Curious Case of the Prosecution of Lawyer Paul Kellogg  March/April 2009
  Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision  March 16, 2009
  Making the Most of Pre-IDE Meetings  March 1, 2009
  Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing  January 2009
  Imported Products - FDA Is Not Fooling Around  January 2009
  FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress  January 2009
  Taking control of the IVD submission process  January 2009
  Dietary Supplement Labeling and Advertising Claims: Are Clinical Studies on the Full Product Required?  2009
  Adroit Crafting of "Intended Use" Critical - Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words  November 15, 2008
  A Bad Fit: Qui Tam Actions and Off-Label Use Allegations  November 2008
  Surprise!...That Food Is Now a Drug  October 2008
  What is Natural?  September 2008
  Personalized Medicine - Panacea or Pipedream?  September 2008
  Cosmetics Product Enforcement - Not an Oxymoron  September 2008
  Lessons Learned from the AbTox Ruling  September 2008
  Ads Can Do the Body Good  September 8, 2008
  Dietary Supplement GMPs: Legal Perspectives  September 2008
  Food Allergens: Legal Requirements  September 2008
  Checking the Box Can Get You in the Hot Seat  August 2008
  Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires  August 1, 2008
  PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum  July 10, 2008
  Cosmetics Labeling and Process for Assigning INCI Names  July 2008
  Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now  July 1, 2008
  FDA Nutrition Labeling Requirements  July 2008
  Voluntary Labeling Claims  July 2008
  Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers  June 2008
  FDA's Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities  June 13, 2008
  FDA Moves Against Marketed Unapproved Human Drugs  May/June 2008
  The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA  May/June 2008
  The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones  May 2008
  FDA's latest ASR guidance document creates more confusion and raises legal issues  April 2008
  FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs  April 2008
  Playing "Hard Ball" With FDA Might Lead to Criminal Prosecution  April 2008
  As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?  April 2008
  Nutrition Labeling - A Look at FDA's Proposed Requirements  February 2008
  FDAAA Enforcement Summary  February 2008
  FDA Regulation of Nanotechnology: What Are the Rules of the Road?  February 2008
  Court case determines specimen ownership  January 2008
  Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake  December 18, 2007
  The Pursuit of Civil Money Penalties - An Important Weapon in FDA's Enforcement Arsenal  December 2007
  Food, Dietary Supplements, and Cosmetics  December 2007
  FDA's Regulatory Scheme for Human Tissue  November/December 2007
  FDA Amendments Act - HPM Issues Detailed Summary and Analysis  October 2007
  The OxyContin Case - Something for Everyone  September 2007
  FDA Releases Final Guidance on ASRs  September 14, 2007
  CMS Final Rule on the Drug Rebate Program  August 9, 2007
  BioShield II: A Step in the Right Direction?  July 2007
  FDA Issues Second Draft Version of IVDMIA Guidance  July 25, 2007
  Thinking of Marketing a Weight-Loss or Diet Product?  July 2007
  Who Decides A Company's Fate in FDA Enforcement Matters?  May 2007
  Jeff Gibbs Cited as FDA Law Authority by Federal Appeals Court  May 2007
  HPM Announces New Director and Associate  May 2007
  CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research Policy  April 11, 2007
  Crossing the Line: Kickbacks Come Under Increased Government Scrutiny  April 6, 2007
  CMS Proposes Expanded Use of Part D Data - Will it Stay Confidential?  March/April 2007
  Are Food and Drug Lawyers 'Real' Lawyers?  April 2007
  Questions over FDA's Authority to Regulate Laboratory Developed Tests  March 2007
  ASRs and IVDMIAs: FDA's New Draft Guidances  March 2007
  Abigail Alliance v. von Eschenbach.  March 2, 2007
  Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy  January 30, 2007
  Corporate Compliance Officer - Gatekeeper or Jailbird  January 2007
  Winning Legal Strategies for Food & Drug Companies  January 2007
  Justice Department Alters Its Policies for Prosecuting Business Organizations  December 2006
  Falling Short - Final Guidance on Coverage With Evidence Development  November/December 2006
  FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients  December 12, 2006
  State of the Union: Drug-Device Combinations  November 2006
  FDA Enforcement of the Food Allergen Labeling Law  October 2006
  Pharmaceutical Law R&D 101: Legal Issues During Research and Development  October 4, 2006
  Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill  September 29, 2006
  Application Of Health Care Fraud And Abuse Laws To Pharmaceutical Marketing  September 2006
  Getting CMS Reimbursement for Medical Technology Products  September 7, 2006
  CMS Proposed Changes to ASP Calculation Methodology  August 2006
  Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace  August 22-25, 2006
  FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?  August 11, 2006
  Medtronic Reaches Settlement over Allegations of Illegal Physician Payments to Promote Spinal Products  July 18, 2006
  CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence Requirements  July 12, 2006
  Medicare to Reconsider Clinical Trial Policy  July 10, 2006
  New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities  June 2006
  Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study  May 2006
  Safeguarding the Food Supply - FDA Given Sanitary Food Transport Authority  May/June 2006
  District Court Rules on Simvastatin 180-Day Exclusivity  May 5, 2006
  Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and Promotion  May 3, 2006
  Health and Speech Rights at Risk from Attacks on Medical Education  April 12, 2006
  Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing Applications  April 10, 2006
  The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now  April 2006
  Product liability drug case not preempted by FDC Act  March 3, 2006
  Medicare CED: Considerations and Implications  March/April 2006
  Bioshield II: One Step Forward, One Step Back?  March/April 2006
  The Deficit Reduction Act of 2005: Amendments To The Medicaid Rebate Program and Drug Payment  February 2006
  It's The Law: Disgorgement and Restitution  February 2006
  FDA Issues Long-Awaited Prescription Drug Labeling Regulations  January 26, 2006
  Responding to FDA Form 483 and FDA Warning Letters  January 18, 2006
  The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now  2006
  Clinical Trials Disclosure Requirements: Too Much of a Good Thing?  January 2006
  Qualified Health Claims: Creatures of Case Law  November/December 2005
  What You Don't Know about AIP Can Hurt You  November 2005
  Product Jurisdiction - New Developments  October 12, 2005
  Government Investigations: Responding to Requests for Information Including E-Discovery  September 2005
  FDA's Unauthorized User Fee Money Grab  August 12, 2005
  Condition of Approval Studies: FDA Takes A New Look  August 2005
  Just Sign on the Dotted Line?  June 20, 2005
  Exploring other options, Part 2: Facilitating the FDA review process  June 2005
  New Case Raises Doubts on FDA's Authority to Obtain Restitution and Disgorgement  May/June 2005
  Exploring other options, Part 1: The trend toward alternative market pathways  May 2005
  Federal and State Requirements for HCT/Ps: An Overview  May 2005
  Further Protecting the Food Supply -- FDA's Final Rule on Recordkeeping Requirements  May 1, 2005
  Perspectives on FDA's Ephedra Rule and the Court Order  April 27, 2005
  FDA Issues Good Review Management Principles and Practices Guidance Document  April 22, 2005
  FDA Draft Guidance on Exploratory IND Studies  April 22, 2005
  FDA Must Reform Its Arbitrary Drug Name Review Process  January 28, 2005
  FDA's Right to Get Disgorgement Is Threatened  2005
  Expanding FDA's Authority to Protect the Food Supply: Administrative Detention  January/February 2005
  Courts Scrutinize FDA  November 4, 2005
  Comparative Claims: Legally Permissible, But Proceed with Care  September 2004
  Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections  July 2004
  Vermont AWP Disclosure and Drug Marketer Gift Reporting Laws  June 2004
  The Food and Drug Administration's Actions on Ephedra and Androstenedione  2004
  State Regulation of Pharmaceutical Clinical Trials  2004
  FDA's Regulation of Combination Products: The Road Ahead  November 2003
  Close but No Cigar: The WHO Framework Convention on Tobacco Control's Futile Ban on Tobacco Advertising  Fall 2003
  Enforcement and Litigation Conference: Actions Against Competitors  September 23, 2003
  Avoid FDA Problems: Implementing a Corporate Compliance Program  June 5, 2003
  When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel  June 2003
  HIPAA and Drug Company Interactions with Physicians - Beyond Clinical Research  May/June 2003
  First Amendment Protection of Commercial Speech: New Opportunities to Educate Healthcare Providers  May 2003
  FDA's Regulation of Analyte-Specific Reagents  February 2003
  Promoting Devices for Specific Indications Based Upon a General Clearance  February 2003
  Western States Medical Center: A Watershed Moment for FDA's Regulation of Commercial Speech  January/February 2003
  Medical Device Reporting: A Risk-Management Approach  January 2003
  Can FDA Seek Restitution or Disgorgement?  2003
  Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected Speech  2003
  Claims for Functional Foods Under the Current Food Regulatory Scheme  October/November 2002
  U.S. Food and Drug Law and FDA - A Historical Background  July 2002
  First Amendment Implications of Labeling and Advertising Restrictions  June 22, 2002
  What You Say May Be Used Against You  May/June 2002
  How FDA's New Labeling Rule Could Preempt State Law
  FDA's Regulation of Internet Promotion and Advertising  July 2001
  FDA's Crackdown on Cholesterol Structure - Function Claims - A Portent of Policies to Come?  May/June 2001
  Criminal Prosecutions Initiated for the FDA  April 2001
  The Washington Legal Foundation Litigation and Its Aftermath  February 2001
  Marketing Dietary Supplement/OTC Drug Combination Products
  How to Transfer Ownership of a 510(k) Clearance  April 2000
  Sample Promotion Under the New PDMA Final Rules  January/February, 2000
  Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
  Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment  2000
  Keep Current with HPM's FDA Law Blog
  It's the Law: Compliance with FDA's Financial Disclosure Rule  November 1999
  A Voluntary Disclosure Programs for FDA - The Time has Come  1999
  "It's Time to Make A Good Agency Better": The Food and Drug Administration Modernization Act and the First Amendment
  Displaying Investigational and Unapproved Medical Devices According to FDA Policy  October 1997
  The History, Provisions and Implementation of the Generic Drug Enforcement Act of 1992  1994
  The Role of the Department of Justice in Enforcement Matters Relating to the Food and Drug Administration  1991
  Administrative Inspections by the Food and Drug Administration: the Role of the Department of Justice  July 1989