Center for Drugs and Biologics (U.S.)

• Anesthesia and sedation in the dental office
• Guideline for submitting documentation for packaging for human drugs and biologics
• Guideline for submitting documentation for the manufacture of and controls for drug products
• Guideline for submitting documentation for the stability of human drugs and biologics
• Guideline for submitting samples and analytical data for methods validation
• Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
• Guideline for the format and content of the chemistry, manufacturing, and controls section of an application
• Guideline for the format and content of the human pharmacokinetics and bioavailability 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 nonclinical pharmacology/toxicology 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 summary for new drug and antibiotic applications