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Getting to know flow charting-new blog post! 

When it comes to lean biomanufacturing, flow charting is deemed as one of the most basic techniques for defining what is required to operate a particular process...click the link to read the full SCG blog on flow charting.

http://smartconsultinggrp.com/getting-know-flow-charting-lean-biomanufacturing/
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Make sure to check out Smart Consulting Group's latest blog on fishbone analysis! The blog is located on our site:

http://smartconsultinggrp.com/understanding-basics-fishbone-analysis/
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5 US Senators sent a letter to the Office of Management and Budget (OMB) urging the release of a draft guidance proposed by FDA regarding the regulation of laboratory developed tests (LDTs). Read the letter here: 

http://www.hpm.com/pdf/blog/2014-07-02_Deese_LDTs.pdf
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Today, #FDA issued a final order classifying the transcutaneous electrical nerve stimulator for the treatment of headache into Class II (special controls).  The device was assigned the generic name transcutaneous electrical nerve stimulator to treat headache, and was identified as a device used to apply an electrical current to a patients cranium through electrodes placed on the skin.  

http://www.gpo.gov/fdsys/pkg/FR-2014-07-03/pdf/2014-15625.pdf
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Today #FDA issued several policy documents regarding compounded drug products for human use. Full news release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403507.htm
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Today's News: Yesterday, FDA announced the approval of Argo Medical Technologies’ ReWalk, a motorized device intended to act as an exoskeleton for individuals with lower body paralysis (paraplegia) due to a spinal cord injury. Read the full news release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402970.htm
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Have them in circles
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#FDA NEWS: Yesterday, European Commission and the European Federation for Pharmaceutical Industries and Associations (EFPIA) announced Europe’s second Innovative Medicines Initiative (IMI 2), which aims to fast-track development of the next generation of medicines, with a focus on areas of unmet medical or societal need. 

The program will launch with a focus on type 1 diabetes and retinal diseases, and develop new methods and tools that accurately reflect the impact of these diseases on patients’ everyday lives. (Pharma Times)
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Today's Industry News: District Court Enters Permanent Injunction Against Joint King Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements. 

Click the link to read further details: http://www.justice.gov/opa/pr/2014/July/14-civ-712.html
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Last week, #FDA approved Spectrum Pharmaceuticals’ Beleodaq (belinostat) for the treatment of patients with peripheral T-cell #lymphoma (#PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403929.htm
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In today's industry news, #FDA  announced availability of a draft guidance for industry entitled, “Current Good Manufacturing Practice – Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.”  

Click the link to read more: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM403496.pdf
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On Friday,  the FDA announced the approval of MannKind Corporation’s Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Read the full news release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm
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Have them in circles
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Smart Pharmaceutical Consultants boosting Pharma Profits with Lean Pharma principles
Introduction

Pharmaceutical Consultants know Lean Pharma is Smart Consulting, but how do you apply Lean Manufacturing principles to the pharma lab with Quality, Compliance and batch size issues and the FDA? It Takes Smart Consulting To Make Pharma Work Better.

You know your business, but sometimes it takes a new pair of eyes, an “outside-the-box” viewpoint from an industry expert that knows smart Pharma lab operations inside out.  A Consultant with experience across a wide range of Pharmaceutical areas, who brings you practical, usable, cost-effective solutions for YOUR particular needs.