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On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software”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


FDA Adopts New Designation Process for Regenerative Advanced Therapies
  • Epstein Becker Green
  • USA
  • February 2 2017

On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced


Congress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts?
  • Epstein Becker Green
  • USA
  • January 25 2017

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If


FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications
  • Epstein Becker Green
  • USA
  • January 20 2017

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s


Stakeholder Agendas in the Washington Transition: 5 Takeaways for Converting Ideas into Technically Effective Proposals
  • Epstein Becker Green
  • USA
  • January 18 2017

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans