Pharma Blog
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
Biological Filing Process to FDA
Biologic filing is the process of submitting an application to the USFDA to request approval for a new biologic product. Biologics are a type of medicine that is made from living organisms or their products. 𝗧𝘆𝗽𝗲𝘀 𝗼𝗳 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗙𝗶𝗹𝗶𝗻𝗴𝘀 𝗧𝗵𝗲𝗿𝗲 𝗮𝗿𝗲 𝘁𝘄𝗼 𝗺𝗮𝗶𝗻 𝘁𝘆𝗽𝗲𝘀 𝗼𝗳 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰 𝗳𝗶𝗹𝗶𝗻𝗴𝘀: 𝗧𝗵𝗲 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗟𝗶𝗰𝗲𝗻𝘀𝗲 ... 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
Difference Between ICH and USFDA Guidelines
ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of pharmaceutical products. However, there are some key differences between the two sets of guidelines in terms of their scope, jurisdiction, ... Read More
How to Prevent Medication Error?
A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional or patient/consumer. Medication incidents can have a devastating impact on: What is a Near Miss? An event that could have resulted in unwanted ... Read More
Dietary Reference Intakes for Iron
Salt form conversion Primary functions Sources Dietary Reference Intake Note: vegetarians may require 1.8-fold greater iron intake as nonheme iron less bioavailable than heme iron. Read also:
Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing
The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB ... Read More
High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be ... Read More
Excel Spreadsheet Validation in Pharmaceutical Industry
What is Excel Spreadsheet? Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which data is laid out in rows and columns — like a big table. Excel organizes data in columns and rows and can perform calculations on that data using formulas. ... Read More
Difference Between 21 CFR Part 11 and EU GMP Annex 11
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance ... Read More
Over-utilization of Proton-Pump Inhibitors
Proton pump inhibitors (PPIs) are among the most commonly used medications in the world. Developed for the treatment and prevention of acid-mediated upper gastrointestinal conditions, these agents are being used increasingly for indications where their benefits are less certain and for indeterminate durations. Long-term PPI use has been associated with ... Read More