post marketing research of drugs refers to the research on the use and effect of drugs following a specific research scheme after they are approved for marketing.
Adverse drug reaction (ADR) refers to the harmful reactions of qualified drugs that are unrelated to the purpose of medication under normal usage and dosage.
If the drug is discontinued or tapered off too quickly, the body's regulation is disrupted, leading to functional issues, symptom resurgence, and worsened disease, known as withdrawal effects.
Drug recall means that drug manufacturers recall drugs that have been sold on the market and have potential safety hazards in accordance with prescribed procedures.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
Dose expansion trials are clinical trials that evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of a new drug or treatment in a larger group of patients than in the initial dose escalation trial.
CBER, or the Center for Biologics Evaluation and Research, is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services (HHS).