On 26 April 2023, the European Commission (EC) proposed reforming the European Union (EU) pharmaceutical legislation. This revision constitutes the first major overhaul of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
Sponsors are generally aware of the commonly held Type B FDA meetings, from pre-IND to End of Phase 2 (EOP2) to pre-NDA/BLA, but how often do you take advantage of additional Type C meetings for agency feedback? Continued discussion and input from the agency can be very beneficial, even outside of the milestones that allow for a Type B Meeting.
According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA.
New Drug Applications – When is it ok to not submit data to FDA? Generally speaking, the FDA wants to see all data collected during drug development – all clinical trials, across all indications, using any formulation of your drug, in any region of the world.
Regulation (EC) No 1901/2006 (the “Pediatric Regulation”) introduced the obligation for Sponsors to apply for a pediatric investigation plan (PIP) early in the drug development process and conduct their pediatric clinical trials accordingly to a PIP agreed with the EMA. Compliance with the Pediatric Regulation is mandatory for any Sponsor seeking marketing authorization for a new medicinal product in the EU.
The accelerated approval pathway has been instrumental in bringing groundbreaking therapies to patients facing serious or life-threatening conditions.
Distinguishing between a medical device and a drug may be challenging to define for some products. We turn our attention to a crucial tool that Sponsors may use to have the FDA classify your product: the Request for Designation (RFD). In this blog, we’ll describe what an RFD entails and its significance in the regulatory realm, providing a comprehensive overview of the process.
Interim sample size adjustments and their many approaches are a frequent discussion point between Sponsors and statisticians during protocol development. One such approach is a blinded assessment of variance, favored by some Sponsors for its lack of alpha penalty. We will discuss how this method works, the pros, the cons, and if this approach might be appropriate for your protocol.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted a harmonized drug-drug interaction (DDI) guidance (ICH M12) in May 2024. The next step is for this guidance to be implemented by ICH members; the FDA and EMA have already implemented the guidance. Read our blog for key highlights of the 2024 ICH M12 Guidance.
Are you developing a new medicinal product for a rare disease and interested in applying for orphan drug designation (ODD) in the European Union (EU)? This blog lists the main areas that you will need to address in your ODD application.
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