ANDA
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
A Comprehensive Comparison between ANDA (Generics) and Biosimilars
Composition ANDA (Generics): Biosimilars: Approval Process ANDA (Generics): Biosimilars: Manufacturing Challenges ANDA (Generics): Biosimilars: Regulation ANDA (Generics): Biosimilars: Market ANDA (Generics): Biosimilars: Analytical Validation ANDA (Generics): Biosimilars: Process Validation ANDA (Generics): Biosimilars: Supply Chain ANDA (Generics): Biosimilars: Read also:
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
ANDA Suitability Petition Vs 505(b)(2)
Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman amendments, was enacted in 1984 to streamline the approval process for generic drugs. Under this law, generic drug manufacturers can file an ANDA to seek approval for a generic version of a previously approved brand-name drug, also ... 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
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More