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Tag Archives: FDA
Margaret Hamburg Uncovered
Judging by the lack of movement on the RSS feeds, most pharma companies gave their employees the day off to celebrate Martin Luther King Day. So, as defacto Pharm Exec photo editor, I thought it might use this quiet time to show off some outtakes from our recent photo shoot with FDA Commissioner Margaret Hamburg, [...]
Posted in People, Pharm Exec Magazine Also tagged Margaret Hamburg, Photo shoot, Photography, Portrait photography Leave a comment
FDA Readies More Warning Letters, Fast Enforcement Action
Image by Getty Images via Daylife
FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many [...]
Posted in FDA Also tagged business, Food and Drug Administration, Food safety, Hamburg, Margaret Hamburg, U.S. Food and Drug Administration, United States Leave a comment
Adverse Event Reports Go Digital Only
Image via Wikipedia
FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions.
“This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
Woodcock Under Investigation
Image by Getty Images via Daylife
An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation by [...]
Takeda Changes Dexlansoprazole Brand Name From Kapidex to Dexilant