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USFDA Guidance: Understanding Certain Postapproval Requirements and Resources for ANDAs
Obtaining FDA approval for an Abbreviated New Drug Application (ANDA) is a major milestone in generic drug development. However, approval is only the beginning of a product's regulatory lifecycle. Generic drug manufacturers must continue to meet numerous postapproval obligations related to product quality, safety monitoring, labeling, manufacturing changes, reporting requirements, and regulatory compliance. To help the industry better understand these responsibilities, the FD
Sharan Murugan
20 hours ago3 min read