Understanding Acceptable – Analytical Method – Submissions
Digesting regulatory guidance is not always easy, but understanding the main points – and then paying attention to the details – will improve your chances of success. Here, I break down the latest analytical guidance into seven bite size chunks to lend a h
Marie Morin |
Preparing a submission for US FDA approval (or approval from any other regulator for that matter) is a laborious business – but your chances of success are greatly increased if it is immediately clear to the reviewer that the documentation meets all of their specific requirements. For analytical methods, it is crucial to describe what you did and how you did it, share your results, and provide proof that the product meets all the criteria – using validated tests. To encourage the preparation of acceptable submissions, the FDA issued a new guidance document in July 2015 titled, ‘Analytical Procedures and Methods Validations for Drugs and Biologics’. The guidance lays out seven key points that need to be included in a submission to support the identity, strength, quality, purity and potency of drug substances and products. It applies whether the submission is a New Drug Application, an Abbreviated New Drug Application, a Biologics Licence Application, a supplement to one of these, or even a Drug Master File.
While this guidance does not contain any information that is new, this is the first time that it has all been assembled in one place so it forms a one-stop shopping guide that provides very clear guidance on exactly what the FDA is looking for.
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