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Results:1-10 of 43

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics
  • Hogan Lovells
  • USA
  • December 11 2018

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage


CMS proposes requiring drug prices in TV ads
  • Hogan Lovells
  • USA
  • October 23 2018

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer


A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing
  • Hogan Lovells
  • USA
  • October 22 2018

Speaking in September at a discussion hosted by the Alliance for a Stronger FDA, Dr. Janet Woodcock provided some candid insight into FDA's


FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions
  • Hogan Lovells
  • USA
  • October 17 2018

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk


U.S. Senate passes bill requiring prescription drug ads to include prices
  • Hogan Lovells
  • USA
  • August 28 2018

On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor


FDA guidances promote greater communication to payors about medical product value, clarify CFL communications
  • Hogan Lovells
  • USA
  • June 14 2018

On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and


FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products
  • Hogan Lovells
  • USA
  • January 26 2018

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall


New Jersey Issues Rules to Chill Drug Manufacturer Payments to Prescribers
  • Hogan Lovells
  • USA
  • January 10 2018

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from


Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders
  • Hogan Lovells
  • USA
  • September 8 2017

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771


Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads
  • Hogan Lovells
  • USA
  • August 22 2017

Yesterday, on August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in