Profound research with poor documentation may not achieve Regulatory approvals. Documenting each section of ANDA demands attentive preparations by medical writers, else the entire development and marketing strategy will be derailed. Besides research protocols, the regulations, restrictions, and legalities that govern scientific and medical information play a vital role in ANDA submissions. Knowledge of Regulatory intricacies, efficient planning and documenting data in the right way will lead to successful submissions.

ANDA submissions demand stringent timelines. To curb costly delays, it is required to employ proficient medical writers to develop the ANDA modules. Medical writers significantly contribute to the development of the following sections of the CTD.

  • Module 5 – Bioequivalence Studies - The complete bioanalytical study methods and reports used in BE studies.
  • Module 2.7 - Clinical Summary – Develop the Data on Bioequivalence (DBE) tables and provide the Safety and Efficacy summaries including Biowaiver justification, wherever applicable.           
  • Apart from Clinical modules development, specific writers need to be employed for CMC, Labeling and Patent & Exclusivity related documents.

Takeaways for Successful ANDA Submission 

Every nook and corner of clinical and nonclinical research data relies on medical and scientific documentation. Here are the important takeaways every medical writer should inculcate in the ANDA application, as guided by the FDA.

Overviews and Summaries: Referred to as Module 2 documents in ANDA CTD format. Module 2 contains the Quality Overall Summary (QOS - providing an overview of the Chemistry, Manufacturing, and Controls) and Clinical Summary (providing bioequivalence data, safety, and Pharmacokinetic parameters). This module should represent the integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation of the pharmaceutical. Generally, Nonclinical Overview, Nonclinical Summary and Clinical Overview are not required for ANDA.

Nonclinical Study Reports: Generally, the ANDAs do not require data for Module 4. But, if any nonclinical study reports or safety assessments are submitted supporting proposed specifications like, toxicology studies to qualify impurities as per the ICH guidance for industry Q3A and Q3B(R2), residual solvents, leachables, or excipients; these reports or assessments should be included as part of the submission in Module 4.

Clinical Study Reports: The data derived from all the clinical studies (Bioequivalence) supporting the ANDA will be part of Module 5. The tabular listings of all clinical studies, biopharmaceutic and bioequivalence studies and the literature references are included.

Conclusively, adhering to the FDA recommendations, medical writers must monitor the compliance of the ANDA as per the applicable guidelines, alongside articulating and documenting the essence of clinical and nonclinical (as applicable) research outcomes in a clear and concise manner.  Submitting inconsistent, inaccurate, or incomplete information in CTD modules lead to refusals based on Refuse to Receive (RtR) guidelines. Refer to an expert Regulatory medical writer for gap analysis and compliant submissions. Stay informed. Stay compliant.


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