M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 25, 2023
July 25, 2023
868061ca-5806-48f0-9ad8-f904ab7868fc
Related Documents
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
Guidance DocumentJuly 18, 2025Center for Drug Evaluation and Research
Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for Industry
Guidance DocumentJuly 31, 2023Center for Drug Evaluation and Research
Questions and Answers | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk: Guidance for Industry
Guidance DocumentJuly 25, 2023Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.