News
RAPS: FDA Offers its Views on Medical Device Trials
11.05.2017
Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array
...
GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC
11.05.2017
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of
...
RAPS: CDRH Warns Three Foreign Medical Device Manufacturers
10.02.2017
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China
...
GMP: MHRA publishes Draft Guidance on "Usability" of Medical Devices
25.10.2016
With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products -
...
GMP: WHO publishes Second Draft of a Global Medical Devices Regulation
25.10.2016
With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro
...
FDA: Use of Electronic Health Record Data in Clinical Investigations
09.06.2016
This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic
...
RAPS: CFDA Begins Overseas Inspections
29.01.2016
CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins
China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign
...
EMA: Draft qualification opinion on the ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials
21.09.2015
Proteus Digital Health Inc. intends to have its Proteus technology approved as a ‘qualified method’ for measuring adherence to medication in clinical trials by associating relevant physiologic
...
GMP: Current FDA Publications for Medical Device Manufacturers
04.09.2015
In irregular intervals, the ECA publishes overviews of the FDA\'s new guidances or draft guidances, webinars, general strategy papers and inspection results concerning medical devices. The
...
RAPS: MHRA Wants Input on Single-Use Device Re-Manufacture Guidance
23.07.2015
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. ...