Searching Content indexed under Healthcare by Erin Bosman ordered by Published Date Descending.
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Committed To Clarity: FDA's Dedication To Transparency With The End Of ASR
On June 21, the Food and Drug Administration (FDA) released a report titled "Statement on agency's efforts to increase transparency in medical device reporting."
United States
15 Jul 2019
Expanding Duties And Eroding Protections For Medical Device Manufacturers
This decision comes as a surprise and represents an unexpected shift in the law with regard to medical device manufacturers.
United States
2 Mar 2017
$4 Billion Price Tag For Pleasing Plaintiffs' Bar? New Study Estimates Costs Of FDA's Proposed Rule On Generic Drug Labeling
An economic consulting group recently published findings that a FDA proposed rule will increase annual healthcare costs by $4 billion.
United States
10 Mar 2014
Driving On Both Sides Of The Road: Supreme Court Hears Bartlett Oral Argument
The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)).
United States
2 Apr 2013
Bill To Undo Mensing Decision And Allow Patients To Sue Generic Drug Makers For Failure To Warn
Senator Patrick Leahy (D-Vt.) introduced legislation yesterday to counter the effect of the Supreme Court's June 2011 decision in Pliva v. Mensing, 131 S. Ct. 2567 (2011).
United States
26 Apr 2012
The Institute Of Medicine’s Broad Recommendations For Replacing The 510(K) Clearance Process
On July 29, 2011, the Institute of Medicine of the National Academy of Sciences released its eagerly awaited report titled, "The FDA 510(k) Clearance Process at 35 Years."
United States
15 Aug 2011
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