Guidelines
Facility Readiness Goal Date Decisions Under GDUFA
The Generic Drug User Fee Amendments (GDUFA) aim to streamline the approval process for generic drugs, ensuring timely access to affordable medications. A crucial aspect of this process is the Facility Readiness Goal Date Decisions, which influence the FDA’s timelines for reviewing and approving generic drug applications. Key Highlights from ... Read More
Explanation of FDA Designations
Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here’s a breakdown of some crucial designations: Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies ... Read More
EU and US GMPs | Understanding the Similarities and Differences
Similarities 1) cover a wide range of products, including RX drugs, OTCs, biologics, & medical devices. Regulations apply to all stages of manufacturing, from raw material sourcing to the final packaging and distribution. 2) require manufacturers to provide adequate training to their employees. 3) prescribe certain standards for facility design ... Read More
Common Terms Used in USFDA Inspections
Types of USFDA Inspections The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications. FDA Forms 482, 483 and 484 Establishment Inspection Report (EIR) A comprehensive report that provides a detailed ... Read More
Patents and Exclusivities | Differences and Importance
Patents Property right issued by USPTO to an inventor “to exclude others from making, using, sale, import the invention into the US for a period of 20 years from the date of filing”. Patents can be issued or expire at any time regardless of the drug’s approval status Patent information ... Read More
Guidelines on Good Distribution Practice of Medicinal Products
Quality Management The organisation’s management is responsible for the quality system, which requires their leadership and active participation supported by staff commitment. The Responsible Person is to ensure that a Quality Management System is implemented and maintained. The Management is to ensure that all parts of the quality system are ... Read More
Qualification and Re-Qualification of Personnel Involved in Laboratory Activities
Qualification and re-qualification of all personnel involved in laboratory activities are critical aspects, which contribute to ensuring the validity of results. This article describes how to manage the qualification of new personnel in the different phases as well ensuring maintenance of competences and the steps to be undertaken to re-qualify ... Read More
Data Quality Framework (DQF) for EU Medicines Regulation
Data Quality (DQ) In general terms, quality is defined as an attribute of a product or service that defines the degree to which it meets customer and other stakeholder needs within statutory and regulatory requirements or its fitness for intended use. Where Data quality is defined as: “fitness for purpose ... Read More
Difference Between CBER and CDER
𝗖𝗕𝗘𝗥 (𝗖𝗲𝗻𝘁𝗲𝗿 𝗳𝗼𝗿 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵) 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝘆: CBER regulates biological products, which are complex substances derived from living organisms or their byproducts. These products include vaccines, blood products, gene therapies, tissues, and medical devices that contain biological components. 𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗰𝗲𝘀𝘀: CBER reviews applications for Biologics License Applications (BLAs) ... Read More
Estimated Time Frames for Obtaining FDA Authorization
𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness. 𝗣𝗿𝗲-𝗜𝗡𝗗 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: 1-2 years𝗜𝗡𝗗: 1-2 years𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀: 3-7 years𝗕𝗟𝗔 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻: 6 months𝗙𝗗𝗔 𝗿𝗲𝘃𝗶𝗲𝘄: 6-12 months𝗧𝗼𝘁𝗮𝗹 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝘁𝗶𝗺𝗲: 5-10 years 𝗕𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 The approval timeline for ... Read More