Medical Cannabis - FDA's Perspective on Research and Drug Development
In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.
First Electronic Product Information (ePI) for Human Medicines
The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?
EMA: Q&A documents on the topic of "Centralised procedures" revised
In September and November 2023, the "Questions & Answers (Q&A)" documents relating to centralised authorisation procedures were revised once again and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.
Clinical Trials Regulation - Version 6.6 of the Q&As
The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.
FDA issues draft Guidance on Confirmatory Evidence of Clinical Trials
The Confirmatory Evidence guidance supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources (e.g., clinical data, mechanistic data, real-world data).
The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture.
EMA releases Youtube Videos of Workshop on Real World Data
The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, Youtube video recordings of both days have been published.
EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.
In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.
Warning Letter to Swiss Manufacturer of Homeopathic Eye Drops
Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.
Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".
The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.
The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.
The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).