EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications
The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.
Improving Registration and Reporting Summary Results Information for Clinical Trials
The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.
Master Protocols for Drug and Biological Product Development
A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.
EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks
As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.
In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.
FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products
Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.
Use of Digital Health Technologies (DHTs) to Acquire Data Remotely
Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.
FDA Exception from the Requirement to obtain Informed Consent
The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the participants.
EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India
Following a good clinical practice (GCP) inspection which showed irregularities in study data, the EMA has recommended the suspension of marketing authorizations of a number of generic medicines tested by a contract research organisation (CRO) located in India.
FDA Publication on Elemental Impurities in Cannabis following Vaporization
Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.
Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.
FDA Launches Electronic Submission Portal for Cosmetics
The FDA issued the final guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA. Amongst others, the guidance contains information about a new electronic registration and listing submission portal: Cosmetics Direct which is now available.
Additional Submission Tools for Cosmetic Product Facility Registration and Product Listing
The FDA announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing. In addition, paper forms are now available.
The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.
FDA enhances Adoption of Innovative Clinical Trial Designs
FDA's Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. The CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.