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Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how...
Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
This webpage provides links to certain publicly available external reports and resources relating to patient experience da...
An FDA Self-Audit of Continuous Manufacturing for Drug Products | Audio Transcript
Preparation is key when managing drug product recalls. It is critical for firms to be “recall ready” so that they can act ...
Considerations for Rescinding Breakthrough Therapy Designation
Considerations for Rescinding Breakthrough Therapy Designation Guidance for Industry
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
eCTD Resources
Electronic submission using the Electronic Common Technical Document (eCTD) can involve the use of several resources.
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination