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Results: 1-10 of 24

FDA Outlines Updated Approach to Regulating Digital Health Technologies
  • Covington & Burling LLP
  • USA
  • December 20 2017

On December 8, FDA addressed the agency's evolving approach to digital health by issuing two new draft guidance documents: "Clinical and Patient


FDA Releases Comprehensive Regulatory Framework for Regenerative Medicine
  • Covington & Burling LLP
  • USA
  • November 21 2017

In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory


FDA Issues Draft Guidance On Best Practices for Convening a GRAS Panel
  • Covington & Burling LLP
  • USA
  • November 17 2017

Earlier this week, FDA issued a long-anticipated draft guidance on best practices to follow when convening an expert panel to evaluate whether a


Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs
  • Covington & Burling LLP
  • USA
  • November 15 2017

On November 16, 2017, the Food and Drug Administration ("FDA" or the "Agency") will hold a public hearing on a proposed approach for sponsors seeking


CMS Revises Medicare Part B Biosimilar Coding and Payment Policies
  • Covington & Burling LLP
  • USA
  • November 8 2017

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services ("CMS") released two final rules addressing changes to Medicare Part B


Practical Considerations for Device Industry Policyholders Experiencing Puerto Rico Hurricane Losses
  • Covington & Burling LLP
  • USA
  • October 25 2017

Last week, FDA released a statement about the challenges facing the medical device manufacturing industry in Puerto Rico in the wake of Hurricanes


FDA Finalizes Guidance on Medical Product Classification
  • Covington & Burling LLP
  • USA
  • October 17 2017

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs


FDA Draft Guidance Addresses Medical Device Status of Microneedling Products
  • Covington & Burling LLP
  • USA
  • October 9 2017

On September 15, 2017, FDA published a draft guidance document titled "Regulatory Considerations for Microneedling Devices" (Draft Guidance). The


FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA
  • Covington & Burling LLP
  • USA
  • September 22 2017

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA). FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA


FDA Reauthorization Act of 2017: Key Provisions Related to Medical Devices
  • Covington & Burling LLP
  • USA
  • September 20 2017

On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 ("FDARA"). Principally