Author: masuuglobal
How to Respond to FDA Form 483 Observations After a Drug CGMP Inspection
Responding to FDA Form 483 Observations After a Drug CGMP Inspection Regulatory checks are very essential in the aspect of making sure that pharmaceutical producers are adhering to the existing requirements of Good Manufacturing Practice (CGMP). In an inspection, U.S. Food and drug administration (FDA) might find conditions that may be against regulatory provisions. Such… Continue reading How to Respond to FDA Form 483 Observations After a Drug CGMP Inspection
FDA Draft Guidance on Biosimilar Development and the BPCI Act – Key Updates for Pharmaceutical Companies
Understanding the FDA Draft Guidance on Biosimilar Development and the BPCI Act (Revision 4) The U.S. Food and Drug Administration (FDA) released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) in March 2026 to clarify regulatory expectations for biosimilar and interchangeable biological products.
What is Quality by Design (QbD) in Regulatory Affairs?
What is Quality by Design (QbD) in Regulatory Affairs? Quality by Design (QbD) in Regulatory Affairs is a systematic, science-based approach to pharmaceutical development that focuses on building quality into a product from the earliest stages rather than testing it at the end.
What is a Pre-IND Meeting for US FDA?
What is a Pre-IND Meeting for US FDA? A Pre-IND meeting for the US FDA is a formal meeting between a drug sponsor and the U.S. Food and Drug Administration (FDA) that takes place before submitting an Investigational New Drug (IND) application. The purpose of this meeting is to obtain regulatory guidance on the planned… Continue reading What is a Pre-IND Meeting for US FDA?
What is a Periodic Benefit-Risk Evaluation Report (PBRER)?
What is a Periodic Benefit-Risk Evaluation Report (PBRER)? A Periodic Benefit-Risk Evaluation Report (PBRER) is a comprehensive pharmacovigilance document submitted by Marketing Authorization Holders (MAHs) to regulatory authorities to evaluate a medicine’s ongoing safety profile and its overall benefit-risk balance. The PBRER provides a structured analysis of new safety data collected during a defined reporting… Continue reading What is a Periodic Benefit-Risk Evaluation Report (PBRER)?
What is a Public Assessment Report (PAR)?
What is a Public Assessment Report (PAR)? A Public Assessment Report (PAR) is an official regulatory document that provides a scientific summary of the evaluation of a medicinal product after it has been approved. It explains how a regulatory authority assessed the quality, safety, and efficacy of a product before granting marketing authorization. The PAR… Continue reading What is a Public Assessment Report (PAR)?
What is Quality Control (QC) in Pharma?
What is Quality Control (QC) in Pharma? Quality Control (QC) in Pharma refers to the set of procedures, testing methods, and documentation practices used to ensure that pharmaceutical products meet predefined quality standards before they are released to the market. QC is a critical component of pharmaceutical manufacturing that focuses on verifying product safety, purity,… Continue reading What is Quality Control (QC) in Pharma?
What is Quality Risk Management (QRM)?
What is Quality Risk Management (QRM)? Quality Risk Management (QRM) is a systematic process used to identify, assess, control, communicate, and review risks that may impact the quality of products or services. It is widely applied in industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing to ensure consistent quality, regulatory compliance, and patient or… Continue reading What is Quality Risk Management (QRM)?
What Is an INAD (Investigational New Animal Drug)?
What Is an INAD (Investigational New Animal Drug)? Investigational New Animal Drug (INAD) is an important aspect in the pharmaceutical and veterinary regulatory environment that facilitates the transfer of innovative animal health products out of the laboratory into the market. An INAD is a regulatory filing by the U.S. Food and Drug Administration (FDA) (via… Continue reading What Is an INAD (Investigational New Animal Drug)?
What is RMP (Risk Management Plan)?
What is RMP (Risk Management Plan)? In the pharmaceutical industry, patient safety is a constant task that extends well beyond clinical development and initial marketing approval. Pharmacovigilance documentation that is arranged methodically and outlines how potential and identified risks of a medication are managed and controlled over the course of its lifecycle is called a… Continue reading What is RMP (Risk Management Plan)?