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Navigating the FDA Reporting Categories with The J. Molner Company

At The J. Molner Company, we have revamped our portfolio of services to support pharmaceutical companies navigating FDA reporting categories, which we outline below.

The United States is currently facing a critical challenge in its healthcare system: drug shortages. These shortages have a deep impact on patients, healthcare providers, and the pharmaceutical industry as a whole. As professionals within the pharmaceutical industry, it is our collective responsibility to address this issue and work towards finding sustainable solutions.

Drug shortages can be attributed to various factors, including manufacturing and quality issues, supply chain disruptions, regulatory challenges, and market dynamics. While some shortages are temporary, others persist for extended periods, posing a significant threat to patient care.

Drug supply has been further disrupted by economic problems and bankruptcy of several big generic pharmaceutical companies. Many FDA-approved drugs are not manufactured and delivered to patients because the product license holders fail to notify the FDA beforehand.

In the evolving field of pharmaceutical regulations, understanding the different FDA reporting categories is crucial to achieving approval compliance and minimizing costs. At The J. Molner Company, we have revamped our portfolio of services to support pharmaceutical companies navigating FDA reporting categories, which we outline below.

Prior Approval Supplement (PAS)

This is used for significant changes to an Abbreviated New Drug Application (ANDA) that require prior FDA approval. Since these changes can impact the safety and efficacy of the pharmaceutical product, PAS submissions are very comprehensive, involving extensive data and documentation.

PAS can include major changes in API and/or Finished Product manufacturing sites and processes, specifications, labeling, artwork etc.

Changes Being Effected (CBE-0/CBE-30)

Changes Being Effected (CBE) submissions typically involve modifications to ANDAs that can have moderate potential to have an adverse effect on the product's safety and efficacy. CBE submissions are divided into two sub-categories:

  • Changes Being Effected (CBE-0): contains changes for which distribution can start once the FDA receives the supplement.

  • Changes Being Effected in 30 Days (CBE-30): require at least 30 days before the distribution of the product.

Minor changes

These changes have minimal potential to affect the product’s entity, strength, quality, purity, or potency. The notification of such changes are appropriately communicated to the FDA as part of the Annual Report.

Benefits of working with The J. Molner Company

With our revamped services, we are well-equipped to assist our clients in successfully navigating the FDA reporting categories, ensuring compliance, minimizing costs, and accelerating the approval process.

Drug shortages pose a significant challenge to patient care and the healthcare system in the United States. As pharmaceutical industry professionals, we must take an active role in addressing this issue. By fostering collaboration, strengthening supply chains, seeking regulatory support, and adopting long-term planning strategies, we can collectively work towards minimizing the impact of drug shortages and ensuring that patients have timely access to the medications they need.


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