November 16, 2021
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).

As of November 11, 2021, about nineteen hundred and forty-eight (1948) PSGs have been documented and released, which can be found here.

Of the forty-eight (48) new drafts added on November 11, twenty-one (21) are revisions of previously published drug-PSGs, and twenty-seven (27) are new.

The new PSGs are spread across oral, intravenous, nasal, subcutaneous, and topical routes, and the dosage forms include powder, solutions, metered sprays, tablets (orally disintegrating and extended- release), chewable bars, solutions, capsules, suspensions, creams, and aerosol foams.

The revised PSGs published by the FDA cover the oral, implantation, injection, and intramuscular routes, with the dosage forms being suspensions, implants, injectables, and tablets (delayed-release, orally disintegrating, and extended-release).

A complete list of the new Product-Specific-Guidelines can be found here.

On November 08, 2021, the US FDA notified further plans of publishing/revising PSGs for fifty-five (55) complex generic products.

These updates bring about a fresh take on each of these products that generics and complex-generic manufacturers need to peruse and ensure their ANDA submissions are compliant. For any support in submission package creation and document-level publishing, reach out to Freyr, a leading global Regulatory solutions and services provider.