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Jones Day Global Privacy & Cybersecurity Update | Vol. 21
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
11 Mar 2019
UK's MHRA Issues Guidance On Health Apps
On August 25, 2016, MHRA issued updated guidance to help identify the health apps that are medical devices and make sure they comply with regulations and are acceptably safe.
28 Sep 2016
First Financial Penalty Decision By The French ANSM
On May 19, 2016, the French National Drug and Health Product Authority ("ANSM") posted on its website its first two financial penalty decisions, adopted on May 12, 2016.
22 Jul 2016
European Commission Publishes Draft Code Of Conduct On Privacy For mHealth Apps
On June 7, 2016, the European Commission published its final draft Code of Conduct on privacy for mobile health apps ("Code").
European Union
20 Jul 2016
FDA Announces Submission To OMB Of Information Collection On Quantitative Information In Direct-To-Consumer Television Advertisements
In the March 18, 2016, Federal Register, FDA announced that a proposed collection of information was submitted to the OMB, titled "Quantitative Information in Direct-to-Consumer Television Advertisements."
United States
13 Apr 2016
AMA Proposes Ban On Advertising Prescription Medical Products To Consumers
On November 17, 2015, physicians at the Interim Meeting of the American Medical Association ("AMA") adopted a new policy calling for a ban on DTC advertising of prescription drugs and medical devices.
United States
23 Nov 2015
CDRH Aims To Focus Regulatory Science On Data Science, Digital Health, Cybersecurity
On October 20, 2015, FDA's Center for Devices and Radiological Health ("CDRH") issued a report on Regulatory Science Priorities (FY2016).
United States
5 Nov 2015
OPDP Warning Letter Targets Social Media Campaign
FDA's Office of Prescription Drug Promotion ("OPDP") issued two warning letters regarding pharmaceutical product promotion in a two-week timeframe, most recently citing social media posts.
United States
18 Aug 2015
District Court Rules Against FDA In Off-Label Marketing Case
Last week, a federal judge in the Southern District of New York granted a preliminary injunction in favor of Amarin Pharma, Inc. ("Amarin") in its dispute against FDA asserting free speech rights to promote an approved drug for unapproved uses based on truthful and nonmisleading communications
United States
17 Aug 2015
Mandatory Use Of Centralized Repository For EU Centralized Procedure Kicks In
As of July 1 2015, it is mandatory to submit centralized procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client.
European Union
11 Aug 2015
FDA Announces Availability Of Safety Reporting Portal And Delays Compliance Date For Electronic Submission Of Post-Market Safety Reports
In the May 27, 2015, Federal Register, FDA announced the availability of the Safety Reporting Portal for the electronic submission of post-market individual case safety reports...
United States
11 Jun 2015
FDA Launches First Drug Shortage Mobile App
FDA launched its first mobile app to speed public access to information about drug shortages.
United States
17 Mar 2015
FDA Revises Draft Guidance On Drug Promotional Materials
FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary."
United States
16 Feb 2015
White House Regulatory Agenda Forecasts Drug And Device Regulations For 2015
The White House's most recent Unified Agenda outlines several major drug and device rules and proposed rules FDA intends to issue in the coming year.
United States
16 Jan 2015
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