With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.
At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.
The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.
The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).
The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.
Decontamination by means of vapour hydrogen peroxide is a well established procedure for isolators. Now, the question is what the expectations of the British Authority MHRA are with regard to sterilisation of direct and indirect contact parts in isolators. Andrew Hopkins - among others chairperson of the working group for the revision of Annex 1 - published his opinion on that.
FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".
Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.
The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.
The FDA published a new guideline on the selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.
Recording temperatures during transport of pharmaceutical products as well as calculating the mean kinetic temperature is essential for assessing a batch with regard to its quality status. How to avoid mistakes when calculating the mean kinetic temperature?
The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.