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Draft Guidance Detailing Good Practices For The ANDA Submission

On 3rd January 2018, Food and Drugs Administration (FDA) published a draft guidance detailing about the good practices for the submission of ANDAs (Abbreviated New Drug Application). This draft consists all of the important things to consider while submission along with highlighting the common deficiencies that may lead to a delay for approval. Mentioned below are some of the highlights from the draft guidance: –

  • The applicants are required to submit proper documents. Notice of paragraph IV certification, Legal action filing, etc should be considered and done in a specified time frame. Also, when a new patent is listed for a Reference Listed Drug, applicant should never file it as serial submissions of amendments to their paragraph IV certifications.
  • The applicants are expected to properly submit the draft container labels. The container labels should have sufficient color differentiation for the different strengths of a drug product. For the parental drug, the applicant should propose package types which should not differ from the type approved by the RLD.
  • It is must for the applicants to provide complete information in their form FDA 356h and in the correct modules in the application. Each and every manufacturing details should be mentioned, i.e. solubility data for the full physiologic pH range, full description of the of the proposed dissolution test, data demonstrating the dissolution methods discriminating ability and information for all strengths of the tests and reference products.
  • It is suggested that in the bioanalytical study report, the applicants should include complete dilution integrity data, analytical raw data, serially selected chromatograms and all the standard operating procedures. If there are any differences in formulations and inactive ingredients existing, then the applicants should provide necessary justifications and documentations addressing these differences. Along with the clinical summary, it is also necessary to provide information on bioequivalence and safety related to in vivo bioequivalence studies.
  • All the manufacturing processes and the impurities along with the quality control record and manual should be reproduced by the applicants. The parameters and the units should be mentioned clearly in the bioanalytical data. It is important to provide explanation about the inactive ingredient regarding why it should be there in the drug composition and in what limits it stays unaffected.

For getting US generic approval on the already existing licensed medication, an ANDA application should be submitted with all the necessary documents in order to avoid any kind of failure or lack. It is essential to know the ANDA Submission Process very well to let it happen legally smooth. The FDA no longer accepts hardcopies of the application. Thus, the applicants must submit their ANDA applications in an eCTD format. The eCTD submission sizes 10 GB and less than this must use the FDA Electronic Submission Gateway (ESG).