The FDA released a draft to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals, according to an article in Regulatory Affairs Professionals Society.
In order to speed the availability of generics, FDA “now will approve a generic drug for which it has made a final determination that the [reference listed drug] RLD was not withdrawn from sale for safety or effectiveness reasons even if that determination has not yet published in the Federal Register, and will proceed with Federal Register publication as expeditiously as is practicable.”
The agency defines a “reference standard” as the drug product selected by FDA that an applicant seeking approval of an abbreviated new drug application (ANDA) must use in conducting a required in vivo bioequivalence study, the article said.
“Now FDA also will consider selecting a new reference standard when the Agency determines that the quantity of the current reference standard in distribution is so limited that a potential ANDA applicant is not able to obtain a sufficient quantity for in vivo bioequivalence testing (even if the current reference standard is not in the Discontinued Section of the Orange Book),” the draft says.
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