Regulatory

News
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Fast-tracking medical devices through the FDA

Starting April 14, the new program will help manufacturers of devices for life-threatening, or irreversibly debilitating, conditions get approval faster.
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News
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Is lack of standardized medical device labeling harming patients?

The FDA is studying if they should require standardized medical device labeling.
News
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Near record lows for medical device recalls

It's been two years since the FDA saw recall numbers this low.
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
News
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FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids

The U.S. Food and Drug Administration on April 1, 2015 issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.
Syringes
Feature Article
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Pharmapack Europe covered lots of ground

Exclusive coverage fom Pharmapack Europe includes strategies for handling injectables, updates on new regs for med devices, and a look at the challenges of veterinary drugs.
News
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FDA issues guidance for repackaging

The U.S. Food and Drug Administration issued a Feb. 2015 Guidance for Industry titled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” that is being distributed for comment purposes only.
Eric Greenberg
Column/Opinion
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Regulators have a range of approaches

What is the best way for a state to assure that people drive safely?
Afrezza (insulin human) Inhalation Powder
Package Case Study
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Sanofi launches Afrezza inhalable insulin for diabetes treatment

Global healthcare company Sanofi and biopharma-ceutical company MannKind Corp. announced that Afrezza (insulin human) Inhalation Powder is now available by prescription in U.S. retail pharmacies nationwide.
Global Data forecast sees significant U.S. pharmaceutical market growth
News
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Forecast sees significant U.S. pharmaceutical market growth

The Patient Protection and Affordable Care Act, faster FDA product approvals, and millions of previously uninsured people potentially entering the patient pool expected to help drive future pharmaceutical growth.
http://www.exair.com/52/hddvce.htm
Machine Product Brief
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Heavy Duty Dry Vacs Are Now CE Compliant

Independent laboratory tests now certify that EXAIR’s Heavy Duty Dry Vac™ meets the rigorous safety, health and environmental standards of the European Union that are required to attain the CE mark. The Heavy Duty Dry Vac is a rugged, industrial duty vacuum cleaner that has been engineered to vacuum high volumes of dry materials in less time than ordinary vacs. The wear resistant design is suitable for the clean-up of abrasive materials like steel shot, garnet, metal chips and sand, yet can also be used for general purpose applications.
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