| 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| Draft Guidance on Medical Device Recalls: Improvements Are Needed July / August 2013 |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| The US FDA and its Draft Guidance on Medical Device Appeals April 2013 |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| A Year in Review: CDRH Draft Guidance Documents of 2011 May / June 2012 |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 |
| Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New Technology 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 |
| Personalized Medicine: Improving the Regulatory Pathway May 2011 |
| Uncertainty Persists with RUO Products - FDA May Be Considering More Restrictive Approach with Research Use Only Assays April 1, 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 |
| The Cost of Inadequate Substantiation November 5, 2010 |
| The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine October 8, 2010 |
| Publish and Perish: A Disturbing Trend in the European Union's Regulation of Nutrition Health Claims Made on Foods September / October 2010 |
| New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment 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 |
| Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires August 1, 2008 |
| Checking the Box Can Get You in the Hot Seat August 2008 |
| Cosmetics Labeling and Process for Assigning INCI Names July 2008 |
| PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum July 10, 2008 |
| Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now July 1, 2008 |
| Voluntary Labeling Claims July 2008 |
| FDA Nutrition Labeling Requirements 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 |
| Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and Promotion May 3, 2006 |
| District Court Rules on Simvastatin 180-Day Exclusivity May 5, 2006 |
| Safeguarding the Food Supply - FDA Given Sanitary Food Transport Authority May/June 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 |
| Clinical Trials Disclosure Requirements: Too Much of a Good Thing? January 2006 |
| The Drug Enforcement Administration's Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now 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 |
| State Regulation of Pharmaceutical Clinical Trials 2004 |
| The Food and Drug Administration's Actions on Ephedra and Androstenedione 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 |
| Promoting Devices for Specific Indications Based Upon a General Clearance February 2003 |
| FDA's Regulation of Analyte-Specific Reagents 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 |
| Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment 2000 |
| Keep Current with HPM's FDA Law Blog |
| Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry |
| 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 1989E |
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