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A Blueprint for Helping Children with Rare Diseases

The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children.

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Keeping You Informed: An Update on FDA’s Judicious Use Strategy for Antimicrobial Drugs in Food-Producing Animals

Today, “antibiotic resistance” is a widely recognized concern. With the rise of bacteria that are resistant to many, and in some cases, all standard treatments, scientists and medical professionals are not alone in focusing on this problem.

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FDA Refines Its Thinking on Nanotechnology

FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency

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10 Shocking Medical Mistakes

When you’re a patient, you trust you’re in good hands, but even the best doctor or nurse can make a mistake on you or someone you love.

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First pill to prevent HIV is only for some patients

Physicians applaud the latest step in reducing new HIV cases, but insist that high-risk individuals who take the medication still need to practice safe sex.

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Top Five Trends Changing the Game in Global Healthcare IT

stethoscope in two years, preferring to examine his patients with a handheld ultrasound unit to view a patient’s heart in real-time. In 2012 alone, physicians in the U.S. are expected to increase their use of smartphones and tablets by 81 per cent.

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Global Licensing & Registration

Drug product registration and licensing in Europe, Africa, Asia, the Middle East and South America

Strategy

Global Drug & Medical Device Regulatory Consulting

Global Licensing and Registration, Product Registration Process – a strategy that ensures optimum results, Dossier Preparation for Export and Registration, Writing & Review of- Summaries and Drug Master File