January 22, 2021
General Counsel Internal Investigations Decision Tree for the Energy Industry
January 22, 2021
General Counsel Internal Investigations Decision Tree for the Technology Industry
January 21, 2021
General Counsel Internal Investigations Decision Tree for the Financial Services Industry
January 15, 2021
General Counsel Internal Investigations Decision Tree for the Food and Beverage Industry
January 15, 2021
General Counsel Internal Investigations Decision Tree for the Life Sciences Industry
January 15, 2021
General Counsel’s Decision Tree
January 5, 2021
A Legislative Solution For Medicare Claims Settlement Delays
January 4, 2021
FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates
January 4, 2021
Health Headlines – January 4, 2021
December 31, 2020
Final Rule on VBP, Patient Assistance and Line Extensions Presents Opportunity and Risk for Drug Manufacturers
December 28, 2020
Health Headlines – December 28, 2020
December 21, 2020
Health Headlines – December 21, 2020
December 17, 2020
CMS Proposes New DMEPOS Coverage Policies and Payment Rates, and Seeks to Codify HCPCS Application, Benefit Category and Payment Determination Processes
December 14, 2020
HHS Finalizes 340B Administrative Dispute Resolution Process
December 14, 2020
Health Headlines – December 14, 2020
December 11, 2020
Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud
December 7, 2020
Health Headlines – December 7, 2020
December 2, 2020
Key Takeaways From the 13th Annual King & Spalding Medical Device Summit
November 30, 2020
Europe – Towards a More Harmonized Market for CBD?
November 30, 2020
Health Headlines – November 30, 2020
November 25, 2020
HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors
November 24, 2020
Are Pharma Speaker Programs Facing an Existential Crisis?
November 23, 2020
Health Headlines – November 23, 2020
November 23, 2020
He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform
November 20, 2020
That Will Leave a Mark: FDA’s Shifting Approach to Regulating the Coronavirus Testing Market Creates Confusion, Opportunities, and Enforcement Risk
November 17, 2020
An Evolving Landscape: The FDA's Regulation of Cannabis
November 16, 2020
Health Headlines – November 16, 2020
November 9, 2020
Health Headlines – November 9, 2020
November 2, 2020
Health Headlines – November 2, 2020
October 26, 2020
France - Trial Period for Medical Use of Cannabis-Based Products
October 26, 2020
Avoiding Shareholder Class Actions After FDA Drug Denials
October 26, 2020
Health Headlines – October 26, 2020
October 19, 2020
Health Headlines – October 19, 2020
October 6, 2020
FDA Announces Updates to Two Guidance Documents Concerning Breast Implant Safety and Transparency
October 5, 2020
EUROPE – The General Court Limits the Scope of “Satisfactory Methods” That Must Be Compared for Orphan Drug Designation
October 2, 2020
FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices
September 28, 2020
Health Headlines – September 28, 2020
September 24, 2020
FDA Proposes New Rule Modifying its “Intended Use” Regulations
September 21, 2020
Health Headlines – September 21, 2020
September 10, 2020
EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon
September 8, 2020
Health Headlines – September 8, 2020
September 4, 2020
Congress Introduces Two Privacy Bills to Regulate COVID-19 Related Data
September 3, 2020
New FDA Guidance on Control of Nitrosamine Impurities
September 1, 2020
FDA Continues its Focus on Breast Implant Safety and Transparency with an Eye Toward Improving Regulatory Decision-Making
August 31, 2020
Health Headlines – August 31, 2020
August 25, 2020
Court Dismisses Shareholder Suit Seeking To Recover Stock Drop from FDA Nonapproval of Experimental Drug
August 24, 2020
France – Thresholds for Prior Authorization of Agreements with Healthcare Professionals and for Benefits of Low Value are Finally Out
August 24, 2020
Health Headlines – August 24, 2020
August 21, 2020
How To Launch a Femtech/Telehealth Start Up
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
August 17, 2020
Health Headlines – August 17, 2020
August 10, 2020
Health Headlines – August 10, 2020
August 3, 2020
Health Headlines – August 3, 2020
July 30, 2020
Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs
July 27, 2020
Health Headlines – July 27, 2020
July 20, 2020
Health Headlines – July 20, 2020
July 13, 2020
Health Headlines – July 13, 2020
July 6, 2020
Health Headlines – July 6, 2020
June 29, 2020
Health Headlines – June 29, 2020
June 23, 2020
New Risks, New Rewards, New Exposure
June 15, 2020
Health Headlines – June 15, 2020
June 10, 2020
COVID-19 Vaccine Developers Can Limit Liability From Trials
June 8, 2020
Criminal and Civil Enforcement of the Defense Production Act
June 8, 2020
Health Headlines – June 8, 2020
June 1, 2020
Health Headlines – June 1, 2020
May 26, 2020
Health Headlines – May 26, 2020
May 18, 2020
Health Headlines – May 18, 2020
May 12, 2020
Steps to Limit Exposure to Pharma, PPE Shareholder Lawsuits
May 6, 2020
Health Headlines – May 4, 2020
April 30, 2020
Congress Enacts OTC Monograph Reform
April 27, 2020
Health Headlines - April 27, 2020
April 24, 2020
One More Year: EU Medical Device Regulation Fully Applies on May 26, 2021
April 17, 2020
Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility
April 13, 2020
Health Headlines – April 13, 2020
April 6, 2020
Health Headlines – April 6, 2020
March 30, 2020
Health Headlines – March 30, 2020
March 24, 2020
Tort Immunity under PREP Act and COVID-19 Response Declaration
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic
March 23, 2020
Health Headlines – March 23, 2020
March 19, 2020
FDA Regulatory Issues for Automakers Manufacturing Medical Devices
March 19, 2020
Ruling In HHS Case May Mean More Drug Trial Reporting
March 16, 2020
CMS Releases Section 1135 Waiver in Response to the Novel Coronavirus Pandemic
March 16, 2020
Health Headlines – March 16, 2020
March 10, 2020
FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)
March 9, 2020
Health Headlines – March 9, 2020
March 3, 2020
Foreign Influence Lessons From Research Org FCA Deal
March 2, 2020
Health Headlines – March 2, 2020
March 2, 2020
Chambers Global Practice Guide: Pharmaceutical Advertising
February 28, 2020
Heather Bañuelos to Co-Chair Food and Drug Law Institute’s 2020 Advertising and Promotion for Medical Products Conference
February 28, 2020
2019 Year in Review: FDA Office of Prescription Drug Promotion
February 25, 2020
DOJ Announces FCA Settlement with NIH-Funded Institute Related to Disclosure of Foreign Influence in Research
February 24, 2020
Health Headlines – February 24, 2020
February 17, 2020
Health Headlines – February 17, 2020