New Drug Application Microbiology Review
The Clinical Microbiology information is required only in NDAs for anti-infective drugs. Since these drugs affect microbial, rather than human physiology, reports on the drug's in vivo and in vitro effects on the target microorganisms are critical for establishing product effectiveness.
An NDA's Microbiology section usually includes data describing:
- the biochemical basis of the drug's action on microbial physiology;
- the drug's antimicrobial spectra, including results of in vitro preclinical studies demonstrating concentrations of the drug required for effective use;
- any known mechanisms of resistance to the drug, including results of any known epidemiologic studies demonstrating prevalence of resistance factors; and
- clinical microbiology laboratory methods needed to evaluate the effective use of the drug
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3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
Biomarkers for Drug Development: The Emerging Regulatory Landscape
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Drug Safety Assessment and Risk Minimization in the Development Period
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
