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The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics ...
The Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early ...
Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments ...
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could ...
Visual inspections ensure that visible particulates are not present in products manufactured by an organization. ...
In pharmaceutical manufacturing, there is the need to use sterile water in production and cleaning activities. ...
Non-prescription drug products are classified as over-the-counter (OTC) drug products. OCT products are drugs that ...
A combination product is a product composed of two or more regulated components. Examples of combination products ...
Unapproved prescription drugs propose a significant risk for patients since they haven’t been reviewed for ...
Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). ...
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse ...
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory ...
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