Benefit-Risk Assessment for Product Quality Evaluation
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?
Clinical Trials Regulation - Version 6.1 of the Q&As
The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?
Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.
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.