Guidelines
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 โto 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 drugโs approval status Patent information ... Read More
Guidelines on Good Distribution Practice of Medicinal Products
Quality Management The organisationโs 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: โfitness for purpose ... Read More
Difference Between CBER and CDER
๐๐๐๐ฅ (๐๐ฒ๐ป๐๐ฒ๐ฟ ๐ณ๐ผ๐ฟ ๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ ๐๐๐ฎ๐น๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต) ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐๐๐ต๐ผ๐ฟ๐ถ๐๐: 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. ๐ฅ๐ฒ๐๐ถ๐ฒ๐ ๐ฃ๐ฟ๐ผ๐ฐ๐ฒ๐๐: CBER reviews applications for Biologics License Applications (BLAs) ... Read More
Estimated Time Frames for Obtaining FDA Authorization
๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ 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. ๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years๐๐ก๐: 1-2 years๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 6-12 months๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years ๐๐ถ๐ผ๐๐ถ๐บ๐ถ๐น๐ฎ๐ฟ๐ The approval timeline for ... Read More
Types of FDA Applications for Drugs and Biologics
The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following submission types: An eCTD publishing tool is recommended to automatically create the eCTD sequence folder and file structure. FDA does not recommend specific tool vendors, however, they can be located via internet search. For information ... Read More