Similarity by Design: FDA Withdraws Draft Guidance on Statistical Approaches
After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal. The guidance was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.
Post-Approval Change Management - Does ICH Q12 offer a solution?
ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".
The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.
Regulatory classification of API co-crystals in the US Approval Procedure
To use an active substance in a form which ensures optimum processing is important for an efficient production process; but what does that mean for approval procedures? Read here how the FDA classifies active pharmaceutical ingredients in co-crystalline form during an approval procedure.
On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.
Warning letter: falsified batch records and missing certificates of analysis
The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.