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TXT FDA Cautions on Syringe Pump Flow Problems [2705 Words] [ Price : $8.95]
FDA cautions healthcare professionals that programmable syringe pumps can have flow continuity problems when used to infuse therapies at low flow rates.
08/25/2016
 
 
TXT FDA Guide on ANDA Refusals Related to Impurity Limits [1186 Words] [ Price : $8.95]
FDA posts a guidance on “ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits” — that is intended to help applicants preparing to submit ANDAs and prior approval supplements for approval of a new strength of a drug product.
08/24/2016
 
 
TXT Drug Prices Set on ‘What Market Will Bear’: Study [3105 Words] [ Price : $8.95]
Harvard Medical School researchers say that high U.S. drug prices are caused primarily by FDA-awarded market exclusivity and patents that allow companies to charge what the market will bear.
08/24/2016
 
 
TXT Court Rejects Homeopathic Labeling Suit Settlement [2660 Words] [ Price : $8.95]
A California federal court cites recommendations from seven attorneys general in rejecting a proposed settlement in a homeopathic drug labeling class action suit.
08/24/2016
 
 
TXT FDA Clears Amedica Expanded Valeo II Lateral Lumbar [1179 Words] [ Price : $8.95]
FDA clears an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes.
08/24/2016
 
 
TXT Drug, Device Recalls Up in 2nd Quarter [2826 Words] [ Price : $8.95]
The Stericycle Recall Index shows that drug and medical device recalls were up in the second quarter of 2016 over first quarter totals.
08/24/2016
 
 
TXT Patients Can Reduce Contact Lens Risk: CDC [2786 Words] [ Price : $8.95]
A CDC report calls for promotion activities to inform contact lens wearers of modifiable behaviors that can lead to corneal infections.
08/24/2016
 
 
TXT BioMerieux Offers UDI Guidance Clarifications [2578 Words] [ Price : $8.95]
bioMerieux recommends four changes to an FDA draft guidance on the form and content of unique device identifiers.
08/24/2016
 
 
TXT Companies Recalling More Kogenate/Helixate FS Lots [2664 Words] [ Price : $8.95]
FDA says Bayer has added eight more lots to the two lots of Kogenate FS being recalled due to potency declining faster than expected, while CSL Behring has added 40 lots to its original two-lot recall of Helixate FS.
08/24/2016
 
 
TXT Guidance on Device Patient Preference Info [161 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance on patient preference information for devices, which may inform FDA’s benefit-risk determination in review of PMAs, HDEs and de novo classification requests.
08/24/2016
 
 
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