ANDA Or 505(B)(2): Choosing The Right Abbreviated Approval Pathway For Your Drug
Source: Premier Consulting
By Kristi Miller, SVP, Regulatory Affairs
For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Read about these in the available blog.
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