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An overall goal of pharmaceutical executives is to ensure that the products developed by their companies are approved by the appropriate agencies and marketed appropriately. However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency. At best, not following these […]

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While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program. There are many advantages to a MDSAP for both the medical device manufacturer and regulatory authorities. Developed by the International Medical Device Regulators […]

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What You Should Know About Compounding Pharmacy Laws (503A & 503B) Sections 503A and 503B are significant new laws pertaining to the compounding of pharmaceuticals. As such, any pharmaceutical that manufactures compounded substances or ingredients should understand what they are and how they apply to their operation. What Are Sections 503A and 503B? Sections 503A […]

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April 24, 2015

Form 483s

Most pharmaceutical or medical device companies want to avoid being issued a Form FDA 483. However, as a result of the complexity of the regulatory guidelines, virtually any company involved in the manufacture of pharmaceuticals, biologics, or devices can be subject to receiving one. As such, pharmaceutical executives should understand the significance of receiving a […]

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April 17, 2015

Mock FDA Audits

Mock FDA audits are an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals or medical devices, and become compliance isssues with FDA. As such, pharmaceutical and medical device executives should understand what a mock FDA audit is, why they should arrange for a mock FDA audit to be conducted, and […]

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