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 FEDERAL TRADE COMMISSION CONSUMER PRODUCT SAFETY COMMISSION ENFORCEMENT OTHER MATTERS FIRM NEWS CURRENT DEVELOPMENTS IN THE LAW CONFERENCES WASHINGTON, DC DURHAM, NC Developments in the Law   Keep Current with HPM's FDA Law Blog   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   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   Nutrition Labeling - A Look at FDA's Proposed Requirements  February 2008   FDAAA Enforcement Summary  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   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  04/06/2007   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   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   Bob Dormer Presents at GPhA Fall Technical Conference  October 20, 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   Bioshield II: One Step Forward, One Step Back?  March/April 2006   Medicare CED: Considerations and Implications  March/April 2006   Medical Devices: Safety, Availability, and Liability  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   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   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   Expanding FDA's Authority to Protect the Food Supply: Administrative Detention  January/February 2005   Courts Scrutinize FDA  November 4, 2005   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   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   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   Western States Medical Center: A Watershed Moment for FDA's Regulation of Commercial Speech  January/February 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 Crackdown on Cholesterol Structure - Function Claims - A Portent of Policies to Come?  May/June 2001   Criminal Prosecutions Initiated for the FDA  April 2001   Marketing Dietary Supplement/OTC Drug Combination Products   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   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   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 Administrations: the Role of the Department of Justice  July 1989   FDA's Right to Get Disgorgement Is Threatened   FDA Has Substantial and Sufficient Authority to Regulate Dietary Supplements   Can FDA Seek Restitution or Disgorgement?