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Insights 347 results
Client Alert
November 15, 2021
FDA Makes First Significant Changes to Premarket Medical Device Software Guidance in 16 Years
Client Alert
November 9, 2021
A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making
Client Alert
October 18, 2021
HHS Continues Focus on Women's Health: AHRQ Calls for Data on Telehealth for Women
Article · Source: Chain Drug Review
September 20, 2021
Fulfilling interchangeables’ promise will take work
Thought Leadership
September 9, 2021
Heather Banuelos Joins the Program Committee for DIA’s 2022 Advertising and Promotion Regulatory Affairs Conference
Article · Source: Intellectual Property & Technology Law Journal
September 1, 2021
“Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What Is Required, and What to Expect?
Client Alert
August 27, 2021
FDA Rejects Bids To Market CBD-Based Dietary Supplements
Article · Source: Chamber Litigation Blog
August 26, 2021
Top False Claims Act Developments
Client Alert
August 17, 2021
Revised PhRMA Code Provides Stricter Controls on HCP Speaker Programs
Article · Source: Chamber Litigation Blog
August 12, 2021
Top False Claims Act Developments
Client Alert
August 6, 2021
FDA Finalizes “Intended Use” Regulations
Article · Source: Chamber Litigation Blog
July 29, 2021
Top False Claims Act Developments
Client Alert
Client Alert
July 9, 2021
White House Issues Executive Order on Promoting Competition in the American Economy
Client Alert
June 23, 2021
Pharmaceuticals and Active Pharmaceutical Ingredients - Biden Administration Issues 100-Day Supply Chain Review Report
Client Alert
June 3, 2021
The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps
Article · Source: Law360
May 10, 2021
Justices Must Resolve Off-Label Drug Warning Predicament
Client Alert
May 5, 2021
Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs
COVID-19 Vaccine Updates
April 30, 2021
CDC Says Pfizer and Moderna COVID-19 Vaccines are 94% Effective Against Hospitalization in Older Adults
COVID-19 Vaccine Updates
April 30, 2021
CDC Reveals New Guidelines for Fully Vaccinated Individuals
Article · Source: The Global Legal Post
April 28, 2021
AI's wide open: EU outlines pioneering Artificial Intelligence Act
COVID-19 Vaccine Updates
April 26, 2021
White House COVID-19 Response Team Announces Successful Administration of 200 Million Shots in 100 Days
COVID-19 Vaccine Updates
April 26, 2021
CDC and FDA Lift Recommended Pause on Johnson & Johnson COVID-19 Vaccine
Client Alert
April 23, 2021
EU Sets Global Standard with First Ever Artificial Intelligence Act
COVID-19 Vaccine Updates
April 22, 2021
CDC Publishes Two Reports on Post-Vaccination COVID-19 Outbreaks in Skilled Nursing Facilities
COVID-19 Vaccine Updates
April 22, 2021
HHS Launches “We Can Do This: Live” Initiative to Increase COVID-19 Vaccine Confidence
Client Alert
April 22, 2021
Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid
COVID-19 Vaccine Updates
April 21, 2021
IRS Announces Employer Tax Credit for COVID-19 Vaccination Paid Time Off
Client Alert
April 20, 2021
FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)
COVID-19 Vaccine Updates
April 19, 2021
White House Announces 50 Percent of US Adults Have Received At Least One Dose of a COVID-19 Vaccine
COVID-19 Vaccine Updates
April 16, 2021
CDC and FDA Release Joint Statement on Johnson & Johnson COVID-19 Vaccine
COVID-19 Vaccine Updates
April 16, 2021
HHS Office for Civil Rights Publishes Legal Guidance Around Access to COVID-19 Vaccines for People with Disabilities and Older Adults
Article · Source: Lebensmittel & Recht
April 15, 2021
Brexit – Chancen und Risiken für die europäische Lebensmittelindustrie
COVID-19 Vaccine Updates
April 15, 2021
Pfizer and BioNTech Ask FDA to Approve COVID-19 Vaccine for Children Ages 12 to 15
COVID-19 Vaccine Updates
April 9, 2021
CDC Awards $3 Billion to Expand COVID-19 Vaccine Programs
COVID-19 Vaccine Updates
April 9, 2021
HHS Launches COVID-19 Community Corps
COVID-19 Vaccine Updates
April 7, 2021
CDC Announces Nearly 80 Percent of Teachers, School Staff, and Childcare Workers Received a COVID-19 Vaccine Dose
COVID-19 Vaccine Updates
April 6, 2021
White House Provides Update on Vaccination Program
Newsletter
April 5, 2021
Health Headlines - April 5, 2021
COVID-19 Vaccine Updates
April 1, 2021
FDA Revises Emergency Use Authorization for Moderna COVID-19 Vaccine
Client Alert
COVID-19 Vaccine Updates
March 30, 2021
UNO Pizzeria & Grill Launches Vaccine Concierge Service for Employees
COVID-19 Vaccine Updates
March 29, 2021
White House COVID-19 Response Team Addresses Possible Surge in Coronavirus Cases
COVID-19 Vaccine Updates
March 29, 2021
CDC Publishes Study on Effectiveness of COVID-19 Vaccines
COVID-19 Vaccine Updates
March 26, 2021
Walgreens Announces First Corporate COVID-19 Vaccine Clinics
Client Alert
March 26, 2021
Medicare Coverage Breakthrough Delayed
COVID-19 Vaccine Updates
March 25, 2021
FDA Authorizes Catalent Plant to Help Manufacture Johnson & Johnson COVID-19 Vaccine
COVID-19 Vaccine Updates
March 25, 2021
CDC Publishes Report on Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among Residents of Skilled Nursing Facilities
COVID-19 Vaccine Updates
March 25, 2021
March 24 Vaccine Rollout Updates from the White House COVID-19 Response Team
COVID-19 Vaccine Updates
March 22, 2021
King & Spalding Attorney Ahsin Azim Comments on COVID-19 Vaccine Regulatory Environment
COVID-19 Vaccine Updates
March 22, 2021
EU Officials Weigh Tighter Restrictions on COVID-19 Vaccine Exports to UK
Article · Source: Chambers and Partners
March 19, 2021
Pharmaceutical Advertising
COVID-19 Vaccine Updates
March 17, 2021
White House COVID-19 Response Team Addresses Vaccine Passports
COVID-19 Vaccine Updates
March 17, 2021
Moderna Starts COVID-19 Vaccine Trial for Infants and Young Children
COVID-19 Vaccine Updates
March 16, 2021
CDC Encourages Large Employers to Consider Workplace Vaccination Programs
COVID-19 Vaccine Updates
March 16, 2021
CDC Publishes Second-Dose Completion and Interval Data for the First Two Months of Vaccine Administration
COVID-19 Vaccine Updates
March 16, 2021
CDC Launches Smartphone App to Report COVID-19 Vaccine Side Effects
COVID-19 Vaccine Updates
March 15, 2021
Biden Administration Increases Medicare’s Reimbursement Rates for COVID-19 Vaccine
Client Alert
March 15, 2021
The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities
Newsletter
March 15, 2021
Health Headlines – March 15, 2021
COVID-19 Vaccine Updates
March 15, 2021
HHS Amends PREP Act to Expand the List of Authorized Vaccinators
COVID-19 Vaccine Updates
March 12, 2021
White House Announces All Adults Will be Eligible for Vaccination by May 1
Article
March 11, 2021
Biden Administration - What's Ahead for the Life Sciences Industry?
Article · Source: The New York Law Journal
March 11, 2021
The Importance of Epidemiology To Contextualize Safety Signals Associated With Women's Health Products
COVID-19 Vaccine Updates
March 10, 2021
Biden Administration Plans to Purchase 100 Million Additional Johnson & Johnson Vaccine Doses
COVID-19 Vaccine Updates
March 9, 2021
CDC Issues Guideline on How Fully Vaccinated People Can Visit Safely with Others
Newsletter
March 8, 2021
Health Headlines – March 8, 2021
COVID-19 Vaccine Updates
March 2, 2021
White House Invokes the Defense Production Act to Accelerate Johnson & Johnson Vaccine Production
COVID-19 Vaccine Updates
March 1, 2021
White House Highlights Private Company Efforts to Defeat COVID-19
COVID-19 Vaccine Updates
March 1, 2021
Johnson & Johnson to Distribute 20 Million Vaccine Doses Throughout March
COVID-19 Vaccine Updates
February 27, 2021
FDA Issues Emergency Use Authorization for Janssen COVID-19 Vaccine
COVID-19 Vaccine Updates
February 26, 2021
Private-Public Partnership in Charlotte Publishes Strategies for Safe, Fast, and Equitable Mass Vaccination Events
COVID-19 Vaccine Updates
February 25, 2021
FDA Approves Storage of Pfizer-BioNTech COVID-19 Vaccine at Higher Temperatures
COVID-19 Vaccine Updates
February 23, 2021
Increased Reliance on the DPA to Fight COVID-19 Has Major Impact on Supplies of Other Drugs and Therapies
COVID-19 Vaccine Updates
February 22, 2021
FDA Issues Additional Guidance for Medical Product Developers Addressing Virus Variants
Newsletter
February 22, 2021
Health Headlines – February 22, 2021
COVID-19 Vaccine Updates
February 22, 2021
CDC Publishes Resources from the National Forum on COVID-19 Vaccine
COVID-19 Vaccine Updates
February 22, 2021
February 22 Vaccine Rollout Updates from the White House COVID-19 Response Team
COVID-19 Vaccine Updates
February 19, 2021
White House COVID-19 Response Team Addresses Impact of Severe Weather on Vaccine Rollout
COVID-19 Vaccine Updates
February 19, 2021
CDC Publishes Safety Monitoring Data for the First Month of Vaccination Administration
COVID-19 Vaccine Updates
February 17, 2021
White House COVID-19 Response Team Addresses Johnson & Johnson Vaccine Rollout Plans
COVID-19 Vaccine Updates
February 17, 2021
CDC Publishes Reports on COVID-19 Variants
COVID-19 Vaccine Updates
February 17, 2021
February 16 Vaccine Rollout Updates from the White House
COVID-19 Vaccine Updates
February 16, 2021
Extreme Winter Weather Disrupts Vaccine Distribution
COVID-19 Vaccine Updates
February 16, 2021
U.S. Government and Private Companies Take Steps to Thwart Bad Actors in Vaccine Rollout
Client Alert
February 12, 2021
GSK v. Teva and Induced Infringement by AB-Rated Generics: Where are we now?
COVID-19 Vaccine Updates
February 10, 2021
White House Announces Members of COVID-19 Health Equity Task Force & Plans to Build More Mass Vaccination Centers
COVID-19 Vaccine Updates
February 10, 2021
DHS and FEMA Make Statements Regarding Efforts to Ensure Equity in Vaccine Distribution
COVID-19 Vaccine Updates
February 10, 2021
CDC Publishes Demographic Data for the First Month of the Vaccine Rollout
Feature
February 10, 2021
General Counsel Internal Investigations Decision Tree for the Automotive Industry
COVID-19 Vaccine Updates
February 9, 2021
February 8 Vaccine Rollout Updates from the White House COVID-19 Response Team
Newsletter
February 8, 2021
Health Headlines – February 8, 2021
Client Alert
February 5, 2021
FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts
Client Alert
February 3, 2021
Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023
Client Alert
February 2, 2021
USDA Issues Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans
Newsletter
January 25, 2021
Health Headlines – January 25, 2021