An ounce of prevention: FDA issues guidance on contract manufacturing arrangements for drugs *

USA - June 13 2013
In late May, FDA published a draft guidance entitled, Contract Manufacturing Arrangements for Drugs: Quality Agreements, to clarify the agency's…

Co-authors: Lynn S. Scott, Alan G. Minsk.

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And yet another twist in product liability litigation, preemption and generic drug liability *

USA - April 30 2013
To quote Michael Corleone from the forgettable The Godfather: Part III, "Just when I thought I was out, they pull me back in." In 2011, we thought we…

Co-authors: Alan G. Minsk.

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OIG FY 2013 Work Plan’s effect on pharmaceutical and medical device manufacturers *

USA - October 31 2012
This article is the third in a series of articles discussing the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) Work Plan for the 2013 fiscal year (FY) that was published on October 3, 2012.

Co-authors: Hedy S. Rubinger.

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FDA leaves an orphan out in the cold *

USA - August 29 2012
In what appears to be a first, the Food and Drug Administration (FDA) recently rescinded an orphan drug exclusivity it granted two years ago to a drug company, claiming it made a mistake.

Co-authors: Alan G. Minsk.

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FDA releases final guidance on placement of product proprietary and established names in advertising and promotional labeling *

USA - February 7 2012
The Office of Prescription Drug Promotion (OPDP) in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research issued a final guidance document in January 2012 to clarify the regulations that specify requirements for the placement of a product’s name, size, prominence and frequency in promotional labeling.

Co-authors: Alan G. Minsk.

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