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#FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.
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#HHS Launches GIS-based tool for health disaster readiness http://www.hhs.gov/news/press/2015pres/06/20150623a.html
HHS launches GIS-based tool for health disaster readiness
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Lawmakers in the Senate Health, Education, Labor, and Pensions Committee are circulating draft legislation to create a standalone center at FDA to regulate diagnostics as a distinct regulatory category from medical devices. If passed, the draft would establish a new framework for regulating in vitro clinical tests (IVCTs), including in vitro diagnostic kits and lab-developed tests. (The Gray Sheet)
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Within six years of the introduction of the rotavirus vaccine, hospitalizations for the diarrheal illness had dropped by 94% and hospitalizations for overall gastrointestinal illnesses were cut in half. Those are the findings of CDC-funded research published in JAMA today. The first vaccine, RotaTeq by Merck, was introduced in 2006, followed [...]
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#BIO2015 is awesome! We're excited to take part in this year's event. Who's with us?
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On 12 June 2015, the National Health and Family Planning Commission (NHFPC) of China notified WHO of 15 additional laboratory-confirmed cases of human infection with avian influenza A (H7N9) virus, including 3 deaths.
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Figuring out what disease areas are attracting the most venture funding and deal-related capital in startup and emerging biotech has historically been quite challenging as few if any datasets track it comprehensively. But late last week, on the eve of BIO, a significant piece of analysis should shine some light [...]
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Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products...Check it out here! http://ow.ly/OffmC
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Need help from professional FDA consultants? Take a look at some of our FDA Regulatory Consulting Services and contact our team today. http://smartconsultinggrp.com/fda-regulatory-consulting/fda-consulting-services/
When it comes to FDA regulatory consulting services, count on the consultants of SCG to provide a professional yet personalized approach.
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MBA Focus's profile photo
AFSB's profile photo
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Meet regulatory's profile photo
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Jignesh Prajapati's profile photo
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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.