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Color Additive Petitions

September 24, 2022
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

Medical Devices – USA/Europe Regulatory Updates round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

January 7, 2022
Standards

There are vast amounts of data being collected on patients, for example, in electronic health records (EHR), and disease and patient registries. Such data are commonly called Real World Data (RWD),...

Procedural Aspects for the Consultation to the European Medicines Agency by a Notified Body on Companion Diagnostics

December 31, 2021
Diagnostics

The guidance document aims to provide interested parties in particular notified bodies, device manufacturers, and medicinal product applicants, with appropriate guidance on procedural aspects to facilitate...

Body on Companion Diagnostics, eu medical device regulations, eu medicines agency, Notified Body on Companion Diagnostics

Medical Device Patient Information Leaflets and Implant Cards

December 24, 2021
Medical Device

From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs)...

mdr implant card requirements, Patient information card, patient information leaflet mdr

Anti-Infective Drug Products for the Pediatric Population – Guidance from FDA

December 19, 2021
Standards

The US Food and Drug Administration (FDA) issued final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance provides recommendations for developing...

anti-infective products, antifungals, antiparasitic products, developing anti-infective drugs, development of anti-infective, fda division of anti-infective products, food and drug administration, including antibacterials, pediatric populations