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Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

Source :GMP News 16/11/2016 During its inspections, the FDA has been observing insufficient data integrity quite often in the Far East. Now, European production sites are not always exemplary. A Warning Letter recently published for the Czech Company Interpharm Praha describes considerable deficiencies in the area of quality control with regard …

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Generics: FDA´s New Guidance on Prior Approval Supplements

On October 14, 2016, the US Food and Drug Administration (FDA) published a new Guidance regarding Prior Approval Supplements (PAS). FDA says that “this guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs)”. Specifically, …

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FDA: Updated CDER List for 2016 Guidance Documents

On 8 August 2016, the U.S. Food and Drug Administration (FDA) updated the list of new and revised draft guidances CDER is planning to publish until the end of this year. The following documents are listed under the category “Pharmaceutical Quality /Manufacturing Standards (CGMP)”: Data Integrity and Compliance with CGMP …

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Securing an orphan drug designation (Published in PharmaTimes magazine – November 2016)

By George Underwood Getting an orphan designation isn’t as simple as just targeting a rare disease. Tim Coté, former director of the FDA’s Office of Orphan Products, tackles the most common mistakes companies make “The three most important things for companies tackling rare diseases to get right are regulatory affairs, regulatory …

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FDA approves implantable device that changes the shape of the cornea to correct near vision

June 29, 2016 — The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of …

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FDA warns against the use of homeopathic teething tablets and gels

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and …

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Antibacterial Soap? You Can Skip It — Use Plain Soap and Water

What Makes Soap ‘Antibacterial’ Triclosan and Health Concerns More on the FDA’s Rule Consumers, Keep Washing with Plain Soap and Water When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk …

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Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding

Who’s at Higher Risk of Bleeding How to Settle an Upset Stomach What Else FDA Is Doing The next time you reach for an over-the-counter (OTC) product to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin. Why? Aspirin-containing …

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For Women: The FDA Gives Tips to Prevent Heart Disease

Tips to Reduce Your Risk Menopause and Heart Health Make a Plan, Take Action More women die from heart disease than from any other cause—a staggering one in four American women, according to the Centers for Disease Control and Prevention. But you can take action now to help prevent problems. …

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How to Dispose of Unused Medicines

Drug Disposal Guidelines and Locations Why the Precautions? Environmental Concerns Disposal of Inhaler Products Is your medicine cabinet full of expired drugs or medications you no longer use? How should you dispose of them? Many community-based drug “take-back” programs offer the best option. Otherwise, almost all medicines can be thrown …

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