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Insight 291 results
Client Alert
October 6, 2020
FDA Announces Updates to Two Guidance Documents Concerning Breast Implant Safety and Transparency
Client Alert
October 5, 2020
EUROPE – The General Court Limits the Scope of “Satisfactory Methods” That Must Be Compared for Orphan Drug Designation
Client Alert
October 2, 2020
FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices
Newsletter
September 28, 2020
Health Headlines – September 28, 2020
Client Alert
September 24, 2020
FDA Proposes New Rule Modifying its “Intended Use” Regulations
Newsletter
September 21, 2020
Health Headlines – September 21, 2020
Client Alert
September 10, 2020
EUROPE – Are Revisions of the Orphan Drug Regulation and Adoption of a Regulation on “Unmet Medical Needs” on the Horizon
Newsletter
September 8, 2020
Health Headlines – September 8, 2020
Article · Source: Pratt's Privacy & Cybersecurity Law Report
September 4, 2020
Congress Introduces Two Privacy Bills to Regulate COVID-19 Related Data
Client Alert
September 3, 2020
New FDA Guidance on Control of Nitrosamine Impurities
Client Alert
September 1, 2020
FDA Continues its Focus on Breast Implant Safety and Transparency with an Eye Toward Improving Regulatory Decision-Making
Newsletter
August 31, 2020
Health Headlines – August 31, 2020
Client Alert
August 25, 2020
Court Dismisses Shareholder Suit Seeking To Recover Stock Drop from FDA Nonapproval of Experimental Drug
Client Alert
August 24, 2020
France – Thresholds for Prior Authorization of Agreements with Healthcare Professionals and for Benefits of Low Value are Finally Out
Newsletter
August 24, 2020
Health Headlines – August 24, 2020
Client Alert
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
Newsletter
August 17, 2020
Health Headlines – August 17, 2020
Newsletter
August 10, 2020
Health Headlines – August 10, 2020
Newsletter
August 3, 2020
Health Headlines – August 3, 2020
Client Alert
July 30, 2020
Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs
Newsletter
July 27, 2020
Health Headlines – July 27, 2020
Newsletter
July 20, 2020
Health Headlines – July 20, 2020
Newsletter
July 13, 2020
Health Headlines – July 13, 2020
Newsletter
July 6, 2020
Health Headlines – July 6, 2020
Client Alert
Newsletter
June 29, 2020
Health Headlines – June 29, 2020
Client Alert
June 23, 2020
New Risks, New Rewards, New Exposure
Newsletter
June 15, 2020
Health Headlines – June 15, 2020
Article · Source: Law360
June 10, 2020
COVID-19 Vaccine Developers Can Limit Liability From Trials
Client Alert
June 8, 2020
Criminal and Civil Enforcement of the Defense Production Act
Newsletter
June 8, 2020
Health Headlines – June 8, 2020
Newsletter
June 1, 2020
Health Headlines – June 1, 2020
Newsletter
May 26, 2020
Health Headlines – May 26, 2020
Newsletter
May 18, 2020
Health Headlines – May 18, 2020
Article · Source: Bloomberg Law
May 12, 2020
Steps to Limit Exposure to Pharma, PPE Shareholder Lawsuits
Newsletter
May 6, 2020
Health Headlines – May 4, 2020
Client Alert
April 30, 2020
Congress Enacts OTC Monograph Reform
Newsletter
April 27, 2020
Health Headlines - April 27, 2020
Client Alert
April 24, 2020
One More Year: EU Medical Device Regulation Fully Applies on May 26, 2021
Client Alert
April 17, 2020
Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility
Client Alert
Newsletter
April 13, 2020
Health Headlines – April 13, 2020
Newsletter
April 6, 2020
Health Headlines – April 6, 2020
Newsletter
March 30, 2020
Health Headlines – March 30, 2020
Client Alert
March 24, 2020
Tort Immunity under PREP Act and COVID-19 Response Declaration
Client Alert
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic
Newsletter
March 23, 2020
Health Headlines – March 23, 2020
Client Alert
March 19, 2020
FDA Regulatory Issues for Automakers Manufacturing Medical Devices
Article · Source: Law360
March 19, 2020
Ruling In HHS Case May Mean More Drug Trial Reporting
Client Alert
March 16, 2020
CMS Releases Section 1135 Waiver in Response to the Novel Coronavirus Pandemic
Newsletter
March 16, 2020
Health Headlines – March 16, 2020
Client Alert
March 10, 2020
FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)
Newsletter
March 9, 2020
Health Headlines – March 9, 2020
Client Alert
Article · Source: Law360
March 3, 2020
Foreign Influence Lessons From Research Org FCA Deal
Newsletter
March 2, 2020
Health Headlines – March 2, 2020
Article · Source: Chambers and Partners
March 2, 2020
Chambers Global Practice Guide: Pharmaceutical Advertising
Thought Leadership
February 28, 2020
Heather Bañuelos to Co-Chair Food and Drug Law Institute’s 2020 Advertising and Promotion for Medical Products Conference
Client Alert
February 28, 2020
2019 Year in Review: FDA Office of Prescription Drug Promotion
Client Alert
February 25, 2020
DOJ Announces FCA Settlement with NIH-Funded Institute Related to Disclosure of Foreign Influence in Research
Newsletter
February 24, 2020
Health Headlines – February 24, 2020
Newsletter
February 17, 2020
Health Headlines – February 17, 2020
Newsletter
February 10, 2020
Health Headlines – February 10, 2020
Client Alert
February 7, 2020
FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products
Client Alert
January 27, 2020
HHS Issues Notice of Violation to California for its Universal Abortion Coverage Mandate
Newsletter
January 27, 2020
Health Headlines – January 27, 2020
Client Alert
January 27, 2020
Is Your Hospital Ready for a Pandemic?
Article
January 24, 2020
Top Ten: 3. Value-Based Payments: Ready, Set, Where to Now?
Newsletter
January 21, 2020
Health Headlines – January 21, 2020
Client Alert
January 16, 2020
Congress Holds Hearing on Current & Future Federal Cannabis Policies
Article · Source: Law360
January 16, 2020
HHS Drug Import Proposal Is Unlikely To Succeed
Newsletter
January 13, 2020
Health Headlines – January 13, 2020
Client Alert
January 7, 2020
FDA Issues Proposed Rule and Draft Guidance on Drug Importation
Newsletter
January 6, 2020
Health Headlines – January 6, 2020
Article · Source: Thomson Reuters: Wall Street Lawyer
December 31, 2019
Delaware Chancery Court Raises Requirements for Boards of Early-Stage Pharmaceutical Companies to Comply with their Duty of Care
Newsletter
December 23, 2019
Health Headlines – December 23, 2019
Client Alert
December 17, 2019
European Commission Proposal Would Make It Harder for Innovator Companies to Launch Friendly Duplicates (Biosimilars)
Newsletter
December 16, 2019
Health Headlines – December 16, 2019
Newsletter
December 2, 2019
Health Headlines – December 2, 2019
Newsletter
November 25, 2019
Health Headlines – November 25, 2019
Newsletter
November 18, 2019
Health Headlines – November 18, 2019
Newsletter
November 11, 2019
Health Headlines – November 11, 2019
Newsletter
November 4, 2019
Health Headlines – November 4, 2019
Client Alert
October 31, 2019
USDA Issues Interim Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans
Article · Source: Morning Consult
October 25, 2019
Compounding Pharmacies Are an Unchecked Threat to Americans’ Health
Newsletter
October 21, 2019
Health Headlines – October 21, 2019
Client Alert
October 17, 2019
HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?
Client Alert
October 14, 2019
Health Headlines – October 14, 2019
Newsletter
October 7, 2019
Health Headlines – October 7, 2019
Client Alert
October 1, 2019
Cannabis Banking Bill Clears U.S. House of Representatives
Newsletter
September 30, 2019
Health Headlines – September 30, 2019
Client Alert
September 27, 2019
FDA Issued Draft Objective Performance Criteria For Five Device Types
Newsletter
September 23, 2019
Health Headlines – September 23, 2019
Newsletter
September 16, 2019
Health Headlines – September 16, 2019
Newsletter
September 9, 2019
Health Headlines – September 9, 2019
Newsletter
September 3, 2019
Health Headlines – September 3, 2019