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Results:1-10 of 84

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


Recent State Court Decisions and FDA Inaction Leave Brand Name Manufacturers Uncertain About Liability for Updating Safety Labeling: The Impact of the “Sameness” Standard
  • Epstein Becker Green
  • USA
  • March 30 2018

Two cases decided over the last three months have added California and Massachusetts to the list of minority states that hold brand name


FDA Guidance on Decision Support Software: Implications for Industry
  • Epstein Becker Green
  • USA
  • January 3 2018

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software”


FDA Issues Final Regulations Easing the Path for Direct-to-Consumer Genetic Testing
  • Epstein Becker Green
  • USA
  • November 8 2017

New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC)


Balancing State and Federal Informed Consent Law
  • Epstein Becker Green
  • USA
  • October 5 2017

The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated


FDA Makes Moves to Advance Digital Health
  • Epstein Becker Green
  • USA
  • August 17 2017

At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health


Commissioner Scott Gottlieb’s Priorities as Newly Approved FDA Commissioner
  • Epstein Becker Green
  • USA
  • May 10 2017

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration ("FDA"). As Commissioner


Trump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know
  • Epstein Becker Green
  • USA
  • April 13 2017

The 21st Century Cures Act (“Cures Act”),1 signed into law by former President Obama on December 13, 2016, sets out a bold