As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. The major markets follow ICH guidelines, which affords...
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On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription...
A Target Product Profile (TPP) serves as the primary strategic framework that aligns commercial and clinical workstreams. When properly defined, the TPP enables drug developers to manage the development equation of risk x cost x time = success, and it...
Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that...
Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. However, in our experience, the answer is this: it is critical that the nonclinical program provides sufficient data...
Analytical Target Profile The analytical target profile (ATP) concept was first introduced in the ICH Q141 Guideline in 2022. This guideline, which compliments the ICH Q22 Guideline, describes science and risk-based approaches for developing and maintaining analytical procedures suitable for...
In 2022, ICH Q14 officially introduced the enhanced approach1 in analytical development as an alternative path to the minimal approach, the benefits of which are worth exploring further. Analytical data is essential in demonstrating the safety and quality of pharmaceutical...
I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....
The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...