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Searching Content indexed under Consumer Protection by Ropes & Gray LLP's Health Care Practice ordered by Published Date Descending.
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Key FDA Officials Signal Approach To Review Of Biosimilar Products
In an article published in yesterday's New England Journal of Medicine ("NEJM"), several key officials with the Food and Drug Administration ("FDA") outlined an approach to review and approval of biosimilars in the United States.
United States
17 Aug 2011
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The OIG Backs Off Intended Exclusion Of Forest Laboratories’ CEO
On August 5, 2011, the Office of the Inspector General, U.S. Department of Health and Human Services (the "OIG"), notified Howard Solomon, the CEO of Forest Laboratories, that the OIG would take no action against him under the permissive exclusion authority accorded the OIG by Section 1128(b)(15) of the Social Security Act ("SSA").
United States
16 Aug 2011
3
Sweeping Changes Under Consideration For "Common Rule" Human Subjects Protection Requirements
On July 22, 2011, the U.S. Department of Health and Human Services ("HHS") announced an Advance Notice of Proposed Rulemaking ("ANPRM") describing comprehensive potential revisions to the Common Rule.
United States
2 Aug 2011
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