FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price
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FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price
On June 5, 2025, FDA announced two proposed monograph orders: 1) Proposed order OTC000038 proposes to make it easier to make (minor) changes to solid oral dosage forms not currently permitted under…
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