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Results:1-10 of 112

FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices
  • Epstein Becker Green
  • USA
  • January 16 2019

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the


FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation
  • Epstein Becker Green
  • USA
  • January 10 2019

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for


FDA to Overhaul Medical Device Approval Process
  • Epstein Becker Green
  • USA
  • December 11 2018

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being


FDA Reexamining Communication Practices with Investigational New Drug Sponsors
  • Epstein Becker Green
  • USA
  • December 6 2018

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess


FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies
  • Epstein Becker Green
  • USA
  • November 20 2018

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to


OIG Publishes Report: FDA’s “Deficient” Cybersecurity Policies and Procedures Need Improvement
  • Epstein Becker Green
  • USA
  • November 15 2018

On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit


FDA Seeks Civil Monetary Penalties Measures to Enforce Compliance with ClinicalTrials.gov Requirements
  • Epstein Becker Green
  • USA
  • October 1 2018

On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials


New Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA
  • Epstein Becker Green
  • USA
  • August 2 2018

Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently


Cheers to 80 Years: Celebrating the Anniversary of the Federal Food, Drug, and Cosmetic Act
  • Epstein Becker Green
  • USA
  • June 25 2018

Eighty years ago today, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). In recognition of this anniversary, EBG


Gail Javitt Quoted in “Three Ways ‘Right-to-Try’ Will Impact Managed Care Organizations”
  • Epstein Becker Green
  • USA
  • June 25 2018

Gail H. Javitt, Member of the Firm in the Health Care & Life Sciences practice, in the Washington, DC, office, was quoted in Managed Healthcare