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Popular RAPS App Back Again for 2016 Regulatory Convergence By Zachary Brousseau - Published 31 August 2016

The RAPS Events app offers users a convenient tool for finding information about sessions, speakers, events and activities; creating personalized agendas; accessing speaker presentation materials; reviewing sessions and speakers; participating in polls and surveys; and sharing comments and photos; as well as a fun way to earn points and prizes.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Regulatory Convergence, RAPS Events, mobile, app

European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016) By Nick Paul Taylor - Published 25 August 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Medical Devices

Tags: medical app, pharmacovigilance, Boehringer, AbbVie

EU Looks to Improve Data Quality of mHealth Apps By Zachary Brennan - Published 25 January 2016

The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health.

Categories: News, Europe, US, EC, FDA, MHRA, Due Diligence, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: mHealth, mobile health apps, mobile health app data, mHealth regulations

Convergence Attendees Can Use New RAPS Mobile App for Info, Fun and Prizes By Zachary Brousseau - Published 14 October 2015

Regulatory Convergence attendees will be able to use the new RAPS Events mobile app to find information about conference sessions, speakers, events and activities; share their own photos and comments; see updates from fellow attendees and earn prizes by completing certain activities.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, mobile app

FDA Takes its Fight Against Drug Shortages to the App Store By Alexander Gaffney - Published 05 March 2015

Drug shortages have been something of an endemic problem in the US for the last several years. For healthcare providers, it can be difficult to tell when a drug is in stock or experiencing a short- or long-term shortage. Now a new mobile application developed by the US Food and Drug Administration (FDA) is hoping to change that.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing

Tags: Drug shortages, App store

One of FDA's Top Device Regulators Stepping Aside By Alexander Gaffney, RAC - Published 19 August 2014

One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Christy Foreman, 510(k), Mobile App Regulation, Leaving, ODE

There's an App for That: China FDA Launches Mobile Drug Regulation Application By Louise Zornoza, RegLink - Published 06 June 2014

The China Food and Drug Administration (CFDA) has launched a "national food and drug regulation" application, or "app," that permits the user to directly access the agency’s rules, regulations, working papers, drug quality announcements, medical device quality bulletins, drug and device recall information, and press releases.

Categories: News, China, CFDA, Compliance, Drugs, Product withdrawl and retirement

Tags: iPhone App, Android App, Software Application, Mobile App

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? By Alexander Gaffney, RAC - Published 15 April 2014

Categories: US, FDA

Tags: Mobile App Guidance, Medical App, Regulatory Explainer, Mobile Medical App, Mobile App, Latest News, medical device

Senate Bill Would Exempt Most Software from FDA Regulation By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA, CDRH

Tags: Medical Software, PROTECT Act, Mobile Medical App, SOFTWARE Act, Mobile App, Latest News, medical device

Mobile App Regulation Focus of Upcoming Legislative Hearing By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: SOFTWARE Act, Mobile Health App, Mobile App, Latest News, Jeffery Shuren, medical device

Stubborn Drug Shortages Lead FDA to Develop Consumer-Focused Mobile App By Alexander Gaffney, RF News Editor - Published 31 October 2013

Categories: US, FDA

Tags: Mobile App, Drug Shortage, Latest News, Drug Shortages

Legislators Propose New Regulatory Definitions for Mobile Health Apps By Alexander Gaffney, RF News Editor - Published 23 October 2013

Categories: US, FDA

Tags: Mobile Medical Applications, Mobile App, Final Guidance, guidance

With Mobile Apps Guidance Now Published, FDA Takes to Twitter to Provide Clarity By Alexander Gaffney, RF News Editor - Published 27 September 2013

Categories: US, FDA

Tags: Mobile Medical Applications, Mobile App, Final Guidance, guidance

Legislator: FDA Should Create New Office to Regulate Mobile Apps By Alexander Gaffney, RF News Editor - Published 11 February 2013

Categories: CDRH

Tags: Honda, Mobile Medical Applications, Apps, Mobile App, Legislation, Applications, Latest News, Bill, Congress, medical device

As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge By Alexander Gaffney - Published 17 April 2012

Categories: FDA

Tags: Apps, Developers, Wireless, Mobile Health, App, House, FCC, mobile, Latest News, Congress

NICE Launching Mobile App For Accessing All Recommendations By Alexander Gaffney - Published 20 March 2012

Categories: NICE

Tags: Mobile App, App, mobile, application, Latest News, guidance