ANDA
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
Key Steps to Minimize the Chances of Getting a RTR from FDA
I am reaching out today to share important information that can help us circumvent any potential issues with Abbreviated New Drug Applications (ANDAs) filed with the FDA. ANDAs are essential for the marketing of generic drugs, and therefore receiving a Refusal to Receive (RTR) can significantly delay approvals. From detailed ... Read More
ANDA Submission and Common Deficiencies
In the world of pharmaceuticals, understanding the ANDA (Abbreviated New Drug Application) submission process is crucial for drug manufacturers seeking approval to market generic drugs. Evaluation Procedure The Food and Drug Administration (FDA) thoroughly evaluates each submitted ANDA to determine if it can be received for review. The concept of ... Read More
Amendments vs Supplements | USFDA
Both amendments and supplements are important tools in the USFDA’s regulatory process with some key differences. Amendment Initiated by the company or requested by the USFDA to make a change to an unapproved application/PAS/tentatively approved application. There are three categories of amendments: major, minor, and unsolicited. Major amendments are changes ... 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