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Virtually every device manufacturer that conducts studies on humans needs to determine whether an investigational device exemption is necessary. As such, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an investigational device exemption if it is needed. What is an Investigational Device Exemption? An […]

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Regulatory compliance training is important for personnel in pharmaceutical and medical device companies to remain current with appropriate regulations. In preparation for announced and unannounced inspections by the Food and Drug Administration, personnel need familiarity with the latest national and international guidelines. As such, pharmaceutical and device executives should understand what features are necessary for […]

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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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