ADVERTISING AND PROMOTION PRESCRIPTION DRUGS AND BIOLOGICS CONTROLLED SUBSTANCES PDMA AND STATE LICENSING OTC DRUGS AND COSMETICS MEDICAL DEVICES IN VITRO DIAGNOSTIC DEVICES FOODS AND DIETARY SUPPLEMENTS ANIMAL DRUGS AND FEEDS TISSUE PRODUCTS PRODUCT JURISDICTION AND COMBINATION PRODUCTS HEALTH CARE CONSUMER PRODUCT SAFETY COMMISSION TOBACCO TRAINING PROGRAMS ENFORCEMENT CORPORATE TRANSACTIONS FIRM NEWS CURRENT DEVELOPMENTS IN THE LAW CONFERENCES Developments in the Law   The US FDA and its Draft Guidance on Medical Device Appeals  April 2013   Federal Taint Teams And Attorney-Client Privilege In Corporate Criminal Investigations  February 2013   Summary of CMS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   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Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools  June 20, 2012   A Year in Review: CDRH Draft Guidance Documents of 2011  May / June 2012   CMS proposed ACA rule - 2-4-2012  April 2012   Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad 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Door: Government Visits To Employees' Homes  August 19, 2011   FDA's Pursuit of Punishing People  July / August 2011   Draft Guidance for RUO Products Issued  August 1, 2011   New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers - More 510(k)s  August 2011   Regulating Molecular Diagnostic Assays: Developing a New Regulatory Structure for a New Technology  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   Just What the Doctor Ordered? Legal Implications of Scheduling and Prescription-Only Approach to Methamphetamine Precursor Regulation  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   Food Allergens: Legal Requirements  September 2008   Dietary Supplement GMPs: Legal Perspectives  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   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   Voluntary Labeling Claims  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   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   The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA  May/June 2008   FDA Moves Against Marketed Unapproved Human Drugs  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   As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?  April 2008   Playing "Hard Ball" With FDA Might Lead to Criminal Prosecution  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   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   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   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   Further Protecting the Food Supply -- FDA's Final Rule on Recordkeeping Requirements  May 1, 2005   Federal and State Requirements for HCT/Ps: An Overview  May 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   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   Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected Speech  2003   Can FDA Seek Restitution or Disgorgement?  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   Keep Current with HPM's FDA Law Blog   Regulation of Labeling and Advertising Claims, in Cosmetic Regulation in a Competitive Environment  2000   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   FDA Has Substantial and Sufficient Authority to Regulate Dietary Supplements