US FDA Issued a New Draft Product-Specific-Guidance (PSG) for Generics Manufacturers
Since 2007, Product-Specific-Guidances (PSGs) have provided the pharmaceutical industry recommendations for manufacturing generic medicinal/drug products. These product-specific guidance documents lay down the United States Food and Drug Administration’s (USFDA) current thought process on the evidence and markers needed to prove and qualify a generic drug being therapeutically equivalent to a Reference Listed Drug (RLD).