FDA Warning Letters for Products Containing CBD and Delta-8 THC
The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.
Data Protection of Information Uploaded in the CTIS
To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.
The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.
MHRA GCP Inspector´s Experience during the COVID-19 Pandemic
The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.
The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.
Version 5 of the Q&As regarding the Clinical Trials Regulation
What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.
ECA comments on FDA Guideline on Visual Inspection
In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.
The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?
UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs
Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?
Updated Guidance relating to Clinical Trials during the COVID-19 Pandemic
The Guidance on the management of clinical trials during the COVID-19 Pandemic has been updated. The key changes are relating to updates with references to the EU Clinical Trials Regulation (CTR) which entered into application on 31 January 2022.