Teledoc, a telehealth services provider looking to do business in Texas, continued its winning streak in Texas federal court: on Monday, a judge rejected the Texas Medical Board’s motion to dismiss Teledoc’s antitrust challenge to the Board’s new rule requiring a “face-to-face visit or in-person …
Minnesota Joins 9-State Compact Expediting Telemedicine Across State Lines
June 30, 2015 Leave a Comment
Effective July 1, 2015, Minnesota will join the Interstate Medical Licensure Compact, a group attempting to expedite the licensing of physicians seeking to provide telemedicine services to patients located in other states. Minnesota joins eight other states in the Compact – Alabama, Idaho, Montana, Nevada, South …
Texas Telemedicine Rule Delayed by Antitrust Suit
June 3, 2015 Leave a Comment
A Texas Medical Board rule requiring a physician to conduct an in-person evaluation before prescribing certain drugs will not go into effect today, June 3, as originally planned. A federal court granted a preliminary injunction to halt enforcement of the rule pending the resolution of an antitrust lawsuit filed by …
FDA Releases Modifications Report
February 27, 2014 Leave a Comment
Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) released its much-anticipate report to Congress on when a modification to a 510(k) medical device triggers the need for submission of a new 510(k). In July 2011, CDRH issued draft guidance that significantly overhauled document K97-1, …
FDA Explains Decision Not to Seek Rehearing in Caronia
January 23, 2013 Leave a Comment
Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …
CDRH Seeks to Assure Device Makers, But Holds Ground
August 31, 2010 Leave a Comment
In an August 31, 2010 webinar, representatives from FDA's Center for Devices and Radiologic Health (CDRH) fielded questions concerning the reports with preliminary recommendations issued earlier this month by the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. …