Jacqueline Berman

Jacqueline Berman

Morgan Lewis

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FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

3/25/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

FDA Flexes Its FSMA Muscles, Initiates Mandatory Recall

Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more

3/13/2013 - FDA FSMA Notice Requirements Product Recalls

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