Category: Regulation

Industry Pharmaceutical Regulation

 Navigating the Regulatory Evolution of NAMs In 2026

The pharmaceutical industry is at the threshold of a historic transformation in how medicine safety is evaluated. For decades, animal models were regarded as the “gold standard” for supporting efficacy and safety prior to human clinical...
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Biotech GLP Pharmaceutical Regulation

Should biomarker bioanalytical methods be validated for a non-clinical tox study

The short answear is: Yes, biomarker bioanalytical methods must be validated for animal toxicity studies, but the rigor of that validation is determined by how the data will be used to make safety or regulatory decisions. In a GLP...
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Chemical Industry Regulation

Key notes of theOECD Guidance on Grouping of Chemicals

  In the rapidly evolving landscape of product safety and drug development, the traditional “test everything” approach is becoming obsolete. Regulatory bodies, including the FDA and ECHA, are increasingly pivoting toward more efficient, humane, and scientifically...
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Pharmaceutical Regulation

The Strategic Role of Pharmacodynamic Assays in Drug Development

In the journey of drug development, we often prioritize Pharmacokinetics (PK)—understanding what the body does to the drug. However, the equally critical counterpart is Pharmacodynamics (PD): the study of what the drug does to the body. PD assays...
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Biotech Pharmaceutical Regulation

Brief summary of safety pharmacology studies

The assessment of safety pharmacology is primarily governed by the ICH S7A (Core Battery) and ICH S7B (Cardiovascular) guidelines. These studies are designed to investigate potential undesirable pharmacodynamic effects on vital functions before human exposure. Here is the comprehensive list...
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Pharmaceutical Regulation Sci&Tech

VEPPANU A Breakthrough of PROTAC

The drug ARV-471, now known by its generic name vepdegestrant and brand name VEPPANU, has made history. As of May 1, 2026, it became the first-ever PROTAC (Proteolysis-Targeting Chimera) to receive FDA approval. Discovered through the pioneering work at Arvinas and detailed in...
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Industry Pharmaceutical Regulation

Learn the keypoint in two minutes: General Considerations for the Use of New Approach Methodologies in Drug Development

The central objective of the FDA’s draft guidance is to establish a rigorous validation framework, ensuring that New Approach Methodologies (NAMs) are reliable and fit-for-purpose for specific regulatory decisions. While “qualification” evaluates a tool’s general utility, validation...
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Biotech Pharmaceutical Regulation

Top CMC Pitfalls in Biologics IND Application and How to Avoid Them

Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...
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Industry Pharmaceutical Regulation Sci&Tech

PBPK Modeling -The Computational Engine Driving Modern Drug Safety

The pharmaceutical industry is undergoing a paradigm shift, moving towards New Approach Methodologies (NAMs) to reduce reliance on traditional animal models. At the forefront of this shift is Physiologically Based Pharmacokinetic (PBPK) modeling, a mechanism-driven computational approach...
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Biotech Industry Pharmaceutical Regulation

List of 2025 FDA New Drug Approvals

In 2025， FDA granted 44 novel drug approvals。This list summarizes the landmark novel therapeutic approvals, categorized by molecular modality and therapeutic area. Drug Name (Active Ingredient) Modality Company Indication Mechanism of Action (MoA) Key Highlights Journavx (Suzetrigine) Small Molecule Vertex...
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