The FDA has published the guidance for industry entitled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The guidance describes various types of regulatory submissions of promotional materials that firms submit to the FDA along with specific recommendations for the content and format for submission in paper copy and electronic format, …
The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia. According to ICH Q8, Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management …
Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain. Ursula Roesler, head of medical devices at QS Zürich AG, told Focus that the medical device department will be closed by the end of October. As far as why the decision was …
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the …
6/13/2019 Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft Draft Guidance for Industry 6/12/2019 ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry
Published EMA Slideshow presentation containing 28 slides about general principals, advice and examples for presenting information in the SmPC of fixed combination medicinal products
Two additional countries to benefit from EU-US mutual recognition agreement for inspections On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) …
Quality Requirements for Drug-Device Combinations EMA/CHMP/QWP/BWP/259165/2019 dated 29th May 2019: https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations). This outlines the dossier data requirements for drug-device combinations (DDCs). The consultation period for this draft runs until 31.08.2019. This is an important draft guideline. The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal …
This is a call for data on the ingredients: Gold (nano), colloidal gold (nano), platinum (nano), colloidal platinum (nano), Copper (nano) and colloidal copper (nano) in the framework of Regulation (EC) 1223/2009. Period of consultation 11 June 2019 – 10 November 2019 The action proposed by the Commission is found on their website.
Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines