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Congressional Committees Propose Restructuring of User Fees in Draft Language

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

FDA Issues Guidance on Expanded Access

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy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 In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

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

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