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TXT HELP Committee Unanimously Supports Califf Nomination [715 Words] [ Price : $8.95]
FDA commissioner-nominee Robert Califf wins an unanimous voice vote from the Senate Health, Education, Labor, and Pensions Committee to approve his nomination to become the next commissioner.
01/12/2016
 
 
TXT Multiple QS Violations at ARB Medical [2796 Words] [ Price : $8.95]
FDAís Minneapolis District Office warns ARB Medical about Quality System violations in its manufacturing of polymeric surgical meshes.
01/12/2016
 
 
TXT High Court Wonít Hear Risperdal Speech Case [407 Words] [ Price : $8.95]
The Supreme Court rejects arguments advanced by two friend-of-the-court briefs and declines to hear an appeal of a South Carolina decision fining Janssen over a Risperdal Dear Doctor letter and the drugís FDA-approved label.
01/12/2016
 
 
TXT CDER Denies Oxtellar BE Petition [2789 Words] [ Price : $8.95]
CDER denies a Supernus Pharmaceuticals petition seeking specific bioequivalence tests for generic forms of Oxtellar XR.
01/12/2016
 
 
TXT More Info Sought on Salt Guidance [2851 Words] [ Price : $8.95]
Companies ask FDA for additional information and clarification of a draft guidance on naming drug products containing salt substances.
01/12/2016
 
 
TXT FDA Clears OptMedís BondEase Skin Adhesive [129 Words] [ Price : $8.95]
FDA clears an OptMed Inc. 510(k) for its BondEase product, a topical skin adhesive intended for the closure of surgical incisions and lacerations as an alternative to sutures and staples.
01/12/2016
 
 
TXT Ballard Spahr Hires DiSpirito for Life Sciences Practice [109 Words] [ Price : $8.95]
The law firm Ballard Spahr hires Neil P. DiSpirito, an attorney with more than 20 years of experience advising pharmaceutical, medical device, and life sciences clients.
01/12/2016
 
 
TXT Class 1 Recall of Thornhill Ventilator Batteries [80 Words] [ Price : $8.95]
Thornhill Research begins a Class 1 recall of its Moves Ventilator lithium polymer batteries because some have been found unresponsive after storage.
01/12/2016
 
 
TXT HELP Committee Wants to Move FDA Legislation Forward: Alexander [196 Words] [ Price : $8.95]
Senate Health, Education, Labor and Pensions Committee chair Lamar Alexander (R-TN) says his committee is still planning to move forward its biomedical innovation/FDA reform bill despite the fact that it is a presidential election year.
01/12/2016
 
 
TXT Comments Sought on Tobacco Restrictions [42 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on regulations restricting the distribution of cigarettes and smokeless tobacco.
01/12/2016
 
 
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