Regulatory compliance is an essential aspect of the Healthcare and Pharmaceutical industries. One crucial aspect of compliance is the submission of various applications to Regulatory authorities. In the United States, the United States Food and Drug Administration (US FDA) plays a significant role in ensuring the safety and efficacy of drugs, medical devices, and biologics. Among the required forms is the FDA 356H Form, which has recently been updated. In this blog, we shall undertake a comparative study of the updated FDA 356H Form and its older version, highlighting the key changes that have been implemented, along with the implications of the changes.

The USFDA has revised the FDA 356H form for new drugs and biologics. The updated form includes the following changes:

  • Changes to the Chemistry, Manufacturing, and Controls (CMC) Section: The updated form now incorporates a new section on CMC, providing comprehensive information on the manufacturing and testing of a drug or biologic. This information is crucial for the USFDA so that they can assess a product’s safety and efficacy.
  • Changes to the Pre-clinical Studies Section: The updated form now includes a new section on pre-clinical studies that provide more detailed information on the animal studies conducted; it aims at assessing the safety of a drug or biologic. This information plays a key role in the USFDA’s evaluation of the potential risks associated with the product in terms of human use.
  • Changes to the Clinical Studies Section: The updated form now includes a new section dedicated to clinical studies that provide detailed information on human studies designed to evaluate the efficacy and safety of a drug or biologic. This information is vital for the USFDA’s benefit-risk assessment of the product in terms of human use.
  • Changes to the Labeling Section: The updated form includes a new section on labeling that provides exhaustive information on the Instructions for Use (IFU) of a drug or biologic. This information helps patients and healthcare providers understand how to use the product safely and effectively.

Changes to the Post-marketing Safety Information Section: The updated form now features a new section on post-marketing safety information that provides details on any safety concerns that may have been identified after the marketing of the drug or biologic. This information is significant for the USFDA as it enables them to monitor the product’s safety and take action accordingly.

The updated FDA 356H form brings to the table significant improvements from the older form, enhancing the overall quality of drug and biological applications submitted to the USFDA. The updated form includes new sections on chemistry, manufacturing, and controls (CMC), pre-clinical and clinical studies, labeling, and post-marketing safety information. These additions ensure that the USFDA has access to detailed information on the product so that the agency can thoroughly assess its safety, efficacy, and potential risks. The updated form aims at streamlining the review process and facilitating faster approvals. However, staying compliant with the US FDA’s regulations can be complex and requires expert guidance. With Freyr’s assistance, manufacturers can confidently meet USFDA’s regulations and focus on delivering safe and effective products to patients. Regular consulting on the USFDA’s official resources is crucial for staying updated with the most current information on the FDA 356H Form and other Regulatory requirements. Contact us to know more!


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