Regulation

Pharmaceutical Regulation

The FDA meeting types under PDUFA

The FDA conducts formal regulatory meetings with drug and biologics sponsors under the Prescription Drug User Fee Act (PDUFA VII) framework. Interactions are categorized by purpose, urgency, and development stage. FDA Formal Meeting Types Meeting Type Purpose &...

GLP Pharmaceutical PopSci Regulation Sci&Tech

In silico, Chemico, vitro methods: GLP or non-GLP

Good Laboratory Practice (GLP) is a formal regulatory quality system (defined by 21 CFR Part 58 and OECD GLP principles) that governs how nonclinical safety studies are planned, performed, monitored, recorded, archived, and reported. Whether an...

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...