· 7/1/2019 – Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry · 7/1/2019 – Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry
The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU good practice guidance for communication to the public on medicines’ availability issues The task force was established by EU regulators to better address potential problems with medicines’ supply and to …
FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease The U.S. Food and Drug Administration announced today that it does not intend to object to the use of certain qualified health claims stating that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary …
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