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Labeling › Final Rules › Pharmaceutical Industry

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

Skadden, Arps, Slate, Meagher & Flom LLP on

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Morgan Lewis - As Prescribed

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more

Akin Gump Strauss Hauer & Feld LLP

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Akin Gump Strauss Hauer & Feld LLP on

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

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