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TXT University of Michigan Gets 8-item 483 After June Inspection [1169 Words] [ Price : $8.95]
FDA issues the University of Michigan an eight-observation Form-483 about pharmacy compounding violations it observed during a June inspection.
08/01/2016
 
 
TXT FDA Piloting New Combination Product Consult Process [1421 Words] [ Price : $8.95]
FDA officials say the agency will begin piloting a new inter-Center consult request procedure for proposed combination products.
08/01/2016
 
 
TXT Sage Recalls 1 Lot of Comfort Shield Cloths [1162 Words] [ Price : $8.95]
Sage Products recalls one lot of Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns.
08/01/2016
 
 
TXT FDA Sets Fees for Outsource Drug Compounders [95 Words] [ Price : $8.95]
Federal Register Notice: FDA announces the rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities for fiscal year 2017.
08/01/2016
 
 
TXT Info on Tobacco Training Programs Guidance Sent to OMB [49 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on tobacco retailer training programs to the Office of Management and Budget.
08/01/2016
 
 
TXT Info on E-Reporting for Compounding Outsourcing Sent to OMB [63 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on electronic product reporting for human drug compounding outsourcing facilities.
08/01/2016
 
 
TXT FDA Seeks Selectors, Nominations for Tobacco Panel [81 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks industry participants for selecting a tobacco grower representative for the Tobacco Products Advisory panel as well as nominations for the representative.
08/01/2016
 
 
TXT Par Complaint Seeks to Ban Potassium Chloride Supplements [186 Words] [ Price : $8.95]
Foley & Larder reports that a complaint on behalf of Par against potassium chloride powder product imports moves to an administrative law judge for review.
08/01/2016
 
 
TXT DC Court Rules for FDA on Marketing Exclusivity [1553 Words] [ Price : $8.95]
The DC federal court rules in FDA’s favor in a lawsuit brought by Otsuka that sought to reverse the agency’s approval of Alkermes’ 505(b)(2) NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension.
08/01/2016
 
 
TXT FDA Approves Transcend Glaucoma Device [1272 Words] [ Price : $8.95]
FDA approves a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combination with cataract surgery.
07/29/2016
 
 
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