Regulation

Pharmaceutical PopSci Regulation

The 25-Year FDA Novel Drug Approval and Indication Matrix

By analyzing historical data from the FDA’s Center for Drug Evaluation and Research (CDER) alongside prominent industry benchmarks over the past 25 years (2001 to 2025), a clear story emerges. CDER approved 951 novel drugs during this period. However, the...

Pharmaceutical PopSci Regulation

The basics about nonclinical toxcitiy study director

What Is a Nonclinical Toxicity Study Director? Before any experimental medicine enters a human body in a Clinical Trial, it must pass a battery of rigorous safety evaluations in the laboratory. At the center of this...

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...

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...

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...

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...

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...

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...

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...

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...