Tobacco use is the common largest preventable cause of disease and mortality in the United States. As part of its
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Regulatory Requirements for Product Stability Testing
One of the crucial part of product development is product stability testing. It is conducted throughout a product’s life cycle.
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Russia Regulatory Compliance Requirements for Life Science Products
Life sciences companies across the globe are witness massive changes. Evolving regulations, rising stakeholder expectations, shifting demographics, emerging science and
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FDA Proposes Ban on Most Powdered Surgical Gloves
On 21st March, 2016, the U.S. Food and Drug Administration (FDA) proposed banning most powdered gloves in the U.S. While
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FDA Reveals New Opioid Labeling
The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid
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Regulatory Requirements for the Labeling of Beverages and Liquid Dietary Supplements
1. General prohibition on false or misleading labeling All claims, statements, and graphics in the labeling of foods, including beverages
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FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue products
As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration issued new guidance
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Ensure Compliance through Effective Root Cause Analysis under FDA’s CAPA Norms
An error can be defined as an action planned but not executed according to the plan. Research by Dr. James
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FDA Top Officials Call for Sweeping Review of Agency’s Opioid Policies
In response to the opioid abuse epidemic, on Monday, Feb 15, 2016, Dr. Robert Califf, the FDA’s Deputy Commissioner for
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Data Standards and e-Submissions for FDA: Policies and Guidance
Approval process of FDA provides consumers benefit from having access to safe and effective medical products and foods. FDA approves
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