Documentation Drug Development Labelling 
FDA Law Blog: Biosimilars
APRIL 8, 2025
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Leading FDAs implementationof the Drug Competition Action Plan (DCAP).
European Pharmaceutical Review
SEPTEMBER 2, 2022
The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.
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pharmaphorum
AUGUST 31, 2021
ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. To be clear, there will always be challenges in drug development, and stakeholders are no stranger to this.
Pharmaceutical Technology
SEPTEMBER 20, 2022
Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Clinical trial packaging and labelling solutions. Trends in clinical packaging.
FDA Law Blog: Biosimilars
OCTOBER 2, 2023
Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. the Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.
Pharmaceutical Technology
SEPTEMBER 15, 2022
The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.
Putting Patients First Blog
APRIL 7, 2025
At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.
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