FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

FINRA Extends Postponement of In-Person Arbitration and Mediation Hearings

By Walter Saurack and James Regan

Due to the COVID-19 epidemic, FINRA has extended the postponement of all in-person arbitration and mediation hearings scheduled through September 4, 2020.  Parties may opt to proceed telephonically or by Zoom or panels may order that that the hearings will take place telephonically or by Zoom.  Hearing postponement will not affect other case deadlines. All case deadlines will continue to apply and must be timely met unless the parties jointly agree otherwise.  FINRA staff will contact affected parties to reschedule or discuss remote scheduling options.

FINRA will also waive postponement fees if parties who have an in-person hearing scheduled from September 7 through December 31, 2020 stipulate to adjourn that hearing.  To avoid postponement fees, parties must provide written notice of the stipulation to adjourn more than 20 days prior to the first scheduled hearing date.

Final CCPA Regulations Submitted For Approval By Attorney General

On June 1, 2020 the California Attorney General (AG) submitted the final text of the CCPA regulations to the California Office of Administrative Law (OAL) for approval.  The final regulations appear to be unchanged from the latest draft published on March 11, 2020.

To read the full text of this post by Duane Morris partner Michelle Donovan, Submitted please visit the TechLaw Blog.