Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. The FDA defines a serious condition as “a disease or...
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Inspection Readiness Program
The Premier Research Quality Assurance (QA) team has developed a unique definition of inspection readiness that is not only inclusive of an organization’s quality culture and continuous improvement mindset but also is applicable across cGxP regulations. The Premier Research’s definition...
The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Unlike the traditional...
The 505(b)(2) pathway offers a strategic avenue for pharmaceutical companies to bring qualifying drugs to market more efficiently. By understanding and optimizing this pathway, companies can expedite drug development, minimize risk, and maximize return on investment, ultimately accelerating the delivery...
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...
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Regulatory Pathway 505(b)(2)...
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...
In May 2024, the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a final draft of the newly developed scientific guidance on drug-drug interaction (DDI) studies, ICH M12, that will be adopted by ICH-abiding regulatory...
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...
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