Publications

Searched Practice: Human Pharmaceuticals

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2013," Covington E-Alert (7/31/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2013," Covington E-Alert (6/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2013," Covington E-Alert (5/30/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2013," Covington E-Alert (4/15/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2013," Covington E-Alert (3/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"China Reorganizes the SFDA and Appoints a New Commissioner," Covington E-Alert (3/25/2013)
Shaoyu Chen Co-Author, Ellen Flannery Co-Author, Mingham Ji Co-Author

"2012 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (3/18/2013)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2013," Covington E-Alert (2/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - December 2012," Covington E-Alert (1/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - November 2012," Covington E-Alert (12/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion," Covington E-Alert (12/7/2012)
Scott Cunningham Co-Author, Ellen Flannery Co-Author, Gerald Masoudi Co-Author, Krista Carver Co-Author, Danielle Barbour Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (12/3/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (10/31/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - August 2012," Covington E-Alert (9/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2012," Covington E-Alert (8/31/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2012," Covington E-Alert (7/26/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2012," Covington E-Alert (6/11/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2012," Covington E-Alert (5/29/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"World Health Organization to Discuss Research and Development Treaty," Covington E-Alert (5/8/2012)
Daniel Spiegel Co-Author, Kristen Eichensehr Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2012," Covington E-Alert (4/30/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Supreme Court Delivers Important Decision on Patent Eligibility," Covington E-Alert (3/23/2012)
Natalie Derzko Co-Author, Ellen Flannery Co-Author, Christopher Sipes Co-Author, Andrea Reister Co-Author, Jeffrey Elikan Co-Author, Paul Berman Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2012," Covington E-Alert (3/22/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2012," Covington E-Alert (2/29/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"2011 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (2/7/2012)
Michael Labson Co-Author, Scott Cunningham Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - December 2011," Covington E-Alert (1/19/2012)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author

"IRS Issues Regulations on Calculation of Branded Prescription Drug Fee," Covington E-Alert (9/1/2011)
Anna Kraus Co-Author, Katherine Phillips Co-Author

"Accountable Care Organization Basics," Covington E-Alert (4/15/2011)
Kevin Shortill Co-Author, Katherine Phillips Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2011," Covington E-Alert (3/9/2011)
Stefanie Doebler Co-Author

"Consumer Product Safety Commission Publishes Consumer Product Safety Database Rule," Covington E-Alert (12/14/2010)
Sarah Wilson Co-Author, Matthew Krauss Co-Author

"Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected," Covington E-Alert (12/13/2010)
Rachel Grunberger Co-Author

"IRS Issues Guidance on Calculation of Branded Prescription Drug Fee," Covington E-Alert (December 2010)

"Summary of FDA Advertising and Promotion Enforcement Activities - September 2010," Covington E-Alert (11/4/2010)

"Summary of FDA Advertising and Promotion Enforcement Activities - August 2010," Covington E-Alert (11/4/2010)

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2010," Covington E-Alert (9/23/2010)

"Mid-Year Update: DDMAC Enforcement Activity," Covington E-Alert (9/7/2010)

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (8/9/2010)

"CMS Releases Final Discount Program Model Agreements," Covington E-Alert (8/3/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (6/3/2010)
Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"Health Care Reform: Annual Fee On Prescription Drug Manufacturers And Excise Tax On Medical Device Manufacturers," Covington E-Alert (4/29/2010)
Anna Kraus Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (4/28/2010)
Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"Health Care Reform: Biosimilars Licensing and Reimbursement," Covington E-Alert (4/12/2010)
Jeffrey Elikan Co-Author, Melissa Whittingham Co-Author

"Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Noellyn Davies Co-Author

"Health Care Reform: Sunshine Provisions," Covington E-Alert (April 2010)
Anna Kraus Co-Author

"Health Care Reform: 340B Drug Pricing Program," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Jennifer Plitsch Co-Author

"Health Care Reform: Medicaid Prescription Drug Reimbursement," Covington E-Alert (April 2010)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Health Care Reform: Medicare Part D Donut Hole and Protected Classes," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"2009 End-Of-Year Summary of DDMAC and APLB Enforcement Activity," Covington E-Alert (1/28/2010)
Peter Safir Co-Author, Scott Cunningham Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author, Stefanie Doebler Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - October 2009," Covington E-Alert (11/30/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - July 2009," Covington E-Alert (8/31/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA’s Final Rules Regarding Expanded Access and Charging for Investigational Drugs and CMS Payment Implications," Covington E-Alert (8/26/2009)
Stefanie Doebler Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - June 2009," Covington E-Alert (7/27/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Proposed Changes to Maine’s Clinical Trial Reporting Regulations," Covington E-Alert (6/29/2009)

"Summary of DDMAC and APLB Enforcement Correspondence - May 2009," Covington E-Alert (6/24/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Department of Defense Releases Additional Guidance for Implementation of the New TRICARE Rule," Covington E-Alert (4/14/2009)
Scott Freling Co-Author, Alan Pemberton Co-Author, Jennifer Plitsch Co-Author

"Trends in DDMAC Enforcement Activity During the Bush Administration," Covington E-Alert (3/30/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"DoD Final Rule Mandates Deeply Discounted Pricing for TRICARE Retail Pharmacy Sales," Covington E-Alert (3/25/2009)
Alan Pemberton Co-Author, Jennifer Plitsch Co-Author, Scott Freling Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - February 2009," Covington E-Alert (3/17/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"U.S. Supreme Court Rejects Federal Preemption in Wyeth v. Levine," Covington E-Alert (3/9/2009)
Scott Danzis Co-Author, Michael Imbroscio Co-Author, Robert Long Co-Author, Paul Schmidt Co-Author

"Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009," Covington E-Alert (3/6/2009)
Anna Kraus Co-Author

"Draft FDA Guidance on Submission and Expedited Review of Abbreviated Laboratory Packages From Accredited Laboratories," Covington E-Alert (2/23/2009)
Jeannie Perron Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - January 2009," Covington E-Alert (2/17/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Launches “Secure Supply Chain” Pilot Program To Improve Safety of Imported Drugs and Drug Ingredients," Covington E-Alert (2/4/2009)
Eric Carlson Co-Author, Jason Ma Co-Author

"FDA Issues Final Guidance on “Good Reprint Practices," Covington E-Alert (1/21/2009)
Scott Danzis Co-Author, Michael Labson Co-Author, Jeannie Perron Co-Author, Peter Safir Co-Author

"Draft Guidance on Good Importer Practices," Covington E-Alert (1/16/2009)
Scott Danzis Co-Author, Jason Ma Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - December 2008," Covington E-Alert (1/15/2009)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - November 2008," Covington E-Alert (12/23/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Opens Offices in China: More Inspections Likely," Covington E-Alert (12/15/2008)
Peter Safir Co-Author, Eric Carlson Co-Author

"First Circuit Upholds New Hampshire Law Banning Sale of Prescriber Information," Covington E-Alert (12/1/2008)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Summary Of DDMAC And APLB Enforcement Correspondence - October 2008," Covington E-Alert (11/18/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"CPSC Issues Rule Relieving Foreign Manufacturers And Private Labelers From Certification Obligation And Allowing Electronic Certifications Under The Consumer Product Safety Improvement Act Of 2008," Covington E-Alert (11/18/2008)
Laura Sim Co-Author

"Summary Of DDMAC and APLB Enforcement Correspondence - July 2008," Covington E-Alert (8/11/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Fifth Circuit Rules that FDA May Regulate Compounded Drugs as “New Drugs” - Update on Medical Center Pharmacy v. Mukasey," Covington E-Alert (7/29/2008)
Jeannie Perron Co-Author, Scott Danzis Co-Author

"PhRMA Issues Revised Code on Interactions with Healthcare Professionals," Covington E-Alert (7/11/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - May 2008," Covington E-Alert (6/9/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Issues Draft Guidance on the Distribution of Journal Articles and Reference Publications on Unapproved New Uses of Approved or Cleared Medical Products," Covington E-Alert (2/19/2008)
Peter Safir Co-Author, Michael Labson Co-Author

"Summary of DDMAC and APLB Enforcement Correspondence - January 2008," Covington E-Alert (2/12/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"FDA Clarifies Recent Initiatives Affecting OTC Drug Labeling," Covington E-Alert (1/30/2008)

"Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (1/18/2008)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (1/3/2008)

"Recalls of FDA-Regulated Products - What You Need to Know," Covington E-Alert (11/6/2007)
Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence - October 2007," Covington E-Alert (11/6/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Food and Drug Administration Amendments Act of 2007," Covington E-Alert (10/2/2007)
Michael Labson Co-Author, Peter Safir Co-Author

"FDA Releases Proposed Rule Amending The Final Monograph for Over-The-Counter Sunscreen Drug Products," Covington E-Alert (9/4/2007)
Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence - July 2007," Covington E-Alert (8/6/2007)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence - May 2007," Covington E-Alert (6/8/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"New Hampshire Prescription Data Ban Ruled Unconstitutional," Covington E-Alert (5/17/2007)
Robert Long Co-Author, Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence - March 2007," Covington E-Alert (4/4/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence - January 2007," Covington E-Alert (2/6/2007)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"Proposed Rules Regarding Requirements for Expanded Access to Investigational Drugs and Charging for Investigational Drugs," Covington E-Alert (1/26/2007)
Peter Safir Co-Author, Michael Labson Co-Author

"FDA Publishes Proposed Rule on Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants," Covington E-Alert (1/19/2007)
Jeannie Perron Co-Author

"CMS Issues Proposed Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (1/12/2007)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"The Dietary Supplement & Nonprescription Drug Consumer Protection Act," Covington E-Alert (12/18/2006)
Jeannie Perron Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (12/7/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (11/6/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence," Covington E-Alert (10/9/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"California Will Negotiate Drug Prices with Manufacturers in New Discount Drug Program," Covington E-Alert (10/9/2006)
Anna Kraus Co-Author, James Snipes Co-Author, Ethan Posner Co-Author, Michael Labson Co-Author

"Western District of Texas Compounding Decision on Medical Center Pharmacy v. Gonzales," Covington E-Alert (9/27/2006)
Jeannie Perron Co-Author, Michael Labson Co-Author

"Proposed Rule Regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs," Covington E-Alert (9/14/2006)
Michael Labson Co-Author, Peter Safir Co-Author

"FDA Proposes Ban of OTC Skin Bleaching Products," Covington E-Alert (8/21/2006)
Jeannie Perron Co-Author

"Recent Trends in DDMAC Enforcement Activity," Covington E-Alert (8/28/2006)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"FDA Approval of Sandoz's 505(b)(2) Application for a Follow-On Recombinant Human Growth Hormone Product," Covington E-Alert (6/5/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Scott Cunningham Co-Author

"Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach: A Divided D.C. Circuit Finds New Due Process Right for the Terminally Ill," Covington E-Alert (5/9/2006)
Peter Safir Co-Author, Michael Labson Co-Author

"The Impact of the Deficit Reduction Act of 2005 on Pharmaceutical Manufacturers," Covington E-Alert (3/3/2006)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Ethan Posner Co-Author

"FDA Final Rule on Prescription Drug Labeling & Statement on Preemption of State Product Liability Laws," Covington E-Alert (1/27/2006)
Peter Safir Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"CMS Issues Ten-Year Record Retention Rule for Medicaid Drug Rebate Program," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Scott Danzis Co-Author

"CMS Establishes PDP and MA Regions," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Michael Labson Co-Author

"Comments Submitted in Response to CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"CMS Issues Guidelines for the Review of Part D Formularies and Procedures; Additional Bidding Information Also Provided," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"Sponsoring a Medicare Part D Prescription Drug Plan," Covington E-Alert (October 2004)
Anna Kraus Co-Author

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Ethan Posner Co-Author

"Medicare Part D: USP Draft Model Guidelines and Public Comment Session," Covington E-Alert (August 2004)
Ellen Flannery Co-Author, Michael Labson Co-Author, Peter Safir Co-Author

"Key Provisions of the CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (August 2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Interim Final Rule," Covington E-Alert (4/14/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author

"Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author