Revised Stability Testing Requirements For Generic Drugs
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Generics Joining The 12-Month Stability Data Club, But “When?” Is Big Question
Generic drug sponsors will need to submit six-month and 12-month stability data for their ANDAs under draft guidance being developed by the Office of Generic Drugs.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.