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Life Sciences › Proposed Rules › Abbreviated New Drug Application (ANDA)

McDermott Will & Emery

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

McDermott Will & Emery on

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information

Sheppard Mullin Richter & Hampton LLP on

On May 31, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations regarding prescription drug product labeling regulations. Under the new rule, each time a prescription drug products is...more

Hogan Lovells

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

Hogan Lovells on

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

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