NDA
Role of QA in New Drug Development and Approval
Introduction The development and approval of new drugs involve a complex process, requiring rigorous quality assurance (QA) measures. QA plays a vital role in ensuring the safety, efficacy, and compliance of new drugs. In this blog, we’ll explore the critical role of QA in new drug development and approval. Why ... Read More
FDA NDA Classification Codes
Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies. The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its ... Read More
Whether to Submit an ANDA or 505(b)(2) Application
(1) A โstand-alone NDAโ is an application submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use. ... Read More
Comparison Between Generic and Branded Product Regulatory Filings
Generic and branded pharmaceutical companies both undergo regulatory filings as part of the drug approval process. While the overarching goal is to ensure safety and efficacy, there are distinct differences in the regulatory requirements and processes for generic versus branded medications. Regulatory Requirements Generic: Branded: Filing Process Generic: Branded: Timelines ... 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
How the ICH Quality Guidelines Fit Into the Drug Development Process
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration ... Read More
Different Phases of Clinical Trials
Pre-clinical (or laboratory) Studies Clinical trials are done only after preclinical findings suggest that the new drug or treatment is likely to be safe and will work in people. Pre-clinical studies, also called laboratory studies, include: Cell Studies Animal studies Phase 0 Studies The IND application must contain certain information, ... Read More