Jacqueline Berman

Jacqueline Berman

Morgan Lewis

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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

6/6/2016 - Clinical Trials Cost Recovery Expanded Access Programs (EAPs) FDA New Guidance Patients Physicians Research and Development

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.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

4/29/2016 - Data Controller Data Integrity Draft Guidance FDA FFDCA Manufacturers Pharmaceutical Industry

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

3/10/2016 - Amarin FDA First Amendment Free Speech Off-Label Promotion Pharmaceutical Industry Prescription Drugs Settlement

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy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 In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more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