An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products-Reference-Cited by-同舟云学术

An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products

Published:2020-02 Issue: Volume:110 Page:104511
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Manning Michael L.,Thompson Matthew D.,Saber Haleh,Maher Virginia E.,Crich Joyce Z.,Leighton John K.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference10 articles.

1. Guidance for Industry, Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-characterized, Therapeutic, Biotechnology-derived Products;FDA,1995

2. Manual of Policies and Procedures 6030.9, Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review;FDA,2013

3. Guidance for Industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products;FDA,2017

4. Guidance for Industry, Rare Diseases: Early drug Development and The Role of Pre-IND Meetings;FDA,2018

5. Guidance for Industry, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations;FDA,2019

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