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Cadila Healthcare Ltd has received a U.S. Food and Drug Administration (FDA) warning letter for violating manufacturing standards at two of its production facilities, the latest in a series of Indian companies to face such action.
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Shares in India's largest drugmaker, Sun Pharmaceutical Industries Ltd, skidded more than 7 percent on Monday after U.S. regulators warned of standards violations at a key plant in the latest blow to India's generic drug industry.
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Yes there will be challenges, not the least of which will be cost concerns, but immunotherapy is coming of age in cancer treatment, said experts at the 2015 Forbes Healthcare Summit.
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Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication for use from use by the military only to use in adults and adolescents in the general populat...
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The mosquito-borne Zika virus has spread to Puerto Rico, leading to travel warnings for tourists, especially pregnant women.
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An avian-like H1N1 virus turned up often in swabs from Chinese pigs, and tests showed that it binds to human receptors and can transmit by respiratory droplets in ferrets.
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FDA REGULATORY AND COMPLIANCE NEWS
• Last week, FDA announced the availability of a draft guidance for industry entitled, “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
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Steve Symekah's profile photo
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Meet regulatory's profile photo
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MBA Focus's profile photo
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.