The US Food and Drug Administration (FDA) has issued a new draft Product-Specific Guidance (PSG) for Generics Manufacturers.
Since 2007, Product-Specific-Guidances (PSGs) have provided recommendations to the pharmaceutical industry for the manufacture of generic medicinal/drug products. These product-specific guidance documents describe the United States Food and Drug Administration’s (USFDA) current consideration on the evidence and markers required to prove and qualify a generic drug is therapeutically equivalent to a Reference Listed Drug (RLD).
Twenty-one (21) of the forty-eight (48) new draughts added on November 11 are revisions of previously published drug-PSGs, and twenty-seven (27) are new.
Powder, solutions, metered sprays, tablets (orally disintegrating and extended-release), chewable bars, solutions, capsules, suspensions, creams, and aerosol foams are among the new PSGs available via oral, intravenous, nasal, subcutaneous, and topical routes.
The FDA’s revised PSGs cover the oral, implantation, injection, and intramuscular routes, with dosage forms such as suspensions, implants, injectables, and tablets (delayed-release, orally disintegrating, and extended-release).
The complete variety of new Product-Specific-Guidelines can be found here.
The US FDA announced new plans to publish/revise PSGs for fifty-five (55) complex generic products on November 8, 2021.
These updates provide a fresh perspective on each of these products, which generics and complex-generic manufacturers must review to ensure their ANDA submissions are compliant. Contact Maven, a leading global Regulatory solutions and services provider, for assistance with submission package creation and document-level publishing.
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