Center for Drugs and Biologics (U.S.)

Guideline for the format and content of the chemistry, manufacturing, and controls section of an application

Guideline for the format and content of the nonclinical pharmacology/toxicology section of an application

Guideline for the format and content of the microbiology section of an application

Guideline for the format and content of the human pharmacokinetics and bioavailability section of an application

Guideline for submitting documentation for the stability of human drugs and biologics

Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances

Guideline on sterile drug products produced by aseptic processing

Guideline on formatting, assembling, and submitting new drug and antibiotic applications

Guideline for submitting documentation for packaging for human drugs and biologics

Guideline for the submission in microfiche of the archival copy of an application

Guideline for submitting samples and analytical data for methods validation

Guideline for submitting documentation for the manufacture of and controls for drug products

Guideline for the format and content of the nonclinical/pharmacology/toxicology section of an application

Guideline for the format and content of the summary for new drug and antibiotic applications

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