Searching Content indexed under Healthcare by Colleen Heisey ordered by Published Date Descending.
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FDA's Evolving Regulation Of Artificial Intelligence In Digital Health Products
FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence.
United States
23 Jan 2018
EU Medical Device Regulation 2017/745 And In Vitro Diagnostic Regulation 2017/746
Below is a high-level summary of some of the key changes brought by the MDR and IVDR to the regulatory framework applicable to medical devices.
European Union
4 Jul 2017
Update On Recommendations And Initiatives Of EU Regulators Ahead Of Brexit
On April 27, 2017, the EMA held a meeting with the heads of the National Competent Authorities of the EU/European Economic Area Member States to discuss the consequences of Brexit...
European Union
12 May 2017
Senate Confirms Dr. Gottlieb's Nomination As FDA Commissioner
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf...
United States
12 May 2017
New York Attorney General Announces Settlements With Three Mobile Health Application Developers
New York has made a mark on the regulatory and enforcement landscape for mobile health applications with the New York Attorney General's March 23, 2017, announcement of settlements...
United States
12 May 2017
GCP Renovation ICH Reflection On "GCP Renovation"
The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.
United States
18 Apr 2017
EFSA Updates Guidance On How To Prepare A Health Claims Application
It also details the kind of information and data applicants need to submit in support of their claim.
European Union
21 Feb 2017
Regulatory Developments Life Sciences Companies Should Expect In The New Presidential Administration
Essential to implementation of the incoming President's agenda is the appointment of senior leaders in the executive departments and administrative agencies responsible for implementing the agenda.
United States
24 Jan 2017
21st Century Cures Act -February 11, 2017, Deadline For Company Disclosure Of Expanded Access Programs
Thus, for those companies that have already initiated a phase 2 or phase 3 study with respect to an investigational drug, the deadline for compliance is February 11, 2017.
United States
19 Jan 2017
FDA Issues Final Rule Related To The Submission Of FDA Import Data In The Automated Commercial Environment
FDA also updated certain sections of FDA regulations related to imports.
United States
28 Dec 2016
FDA Amends Food Labeling Regulations Related To Saturated Fat And Cholesterol
FDA is making the amendment in response to a petition submitted by the American Heart Association.
United States
23 Dec 2016
CSPI Files Petition With USDA To Add Cancer Warnings On Meat And Poultry Products
On December 1, 2016, the Center for Science and the Public Interest requested that USDA's FSIS mandate a warning label on processed meat and poultry products preserved by smoking, curing...
United States
22 Dec 2016
FDA Amends Regulation Regarding Health Claims On Fruits And Vegetables
FDA issued an interim final rule amending the regulation that governs when a food label may make a health claim on the relationship between dietary saturated fat...
United States
22 Dec 2016
European Parliament Calls For Limit On Industrial Trans Fats In Food
On October 26, 2016, Members of European Parliament ("MEPs") resolved to place mandatory limits on industrially produced trans-fatty acids ("TFAs").
European Union
21 Nov 2016
Food, Dietary Supplement & Cosmetics Regulatory Update | Vol. III, Issue 14
The FDA answered a series of questions concerning the compliance dates for various nutrition initiatives, such as the Nutrition Facts Label final rule and the vending machine labeling rule.
United States
2 Nov 2016
EMA Consults On Development Of Medicines To Treat Tuberculosis
The guidance is an addendum to EMA's guideline on the evaluation of medicines to treat bacterial infections.
European Union
29 Sep 2016
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
EU And US eHealth IT Roadmap
The foreseen activities for this new work stream are outlined in the annex to the roadmap and will start in fall/autumn 2016.
27 Sep 2016
Balancing Premarket And Postmarket Data Collection: CDRH Completes Retrospective Review Of PMAS Approved Before 2010 And Seeks Feedback On Results
Firms that are developing a device in an affected category should seek feedback on their data collection plan through a presubmission or contact the appropriate review branch to obtain additional information.
United States
26 Sep 2016
FDA Announces November Hearing On Off-Label Communications
On November 9 and 10, 2016, FDA will host a public hearing to obtain feedback on the Agency's regulation of communications by manufacturers, packers, distributors, and their representatives about FDA-regulated medical products.
United States
23 Sep 2016
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