Latest Posts › Life Sciences

Share:

Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility

In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more

U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic

The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more

FDA Issued Draft Objective Performance Criteria For Five Device Types

Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

AdvaMed Updates Code of Ethics on Interactions with U.S. Health Care Professionals

The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics - The Advanced Medical Technology Association (AdvaMed) published in late December 2018 an updated version of its widely-adopted...more

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

5 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide