Titles
- Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff1
- Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)1
- Child-resistant packaging statements in drug product labeling1
- Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment1
- Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool1
- Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act1
- Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff1
- Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff1
- Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration staff1
- Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff1
- Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions1
- Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff1
- Clinical trial imaging endpoint process standards1
- Community-acquired bacterial pneumonia: developing drugs for treatment1
- Competitive generic therapies1
- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- Compliance policy for limited modifications to certain marketed tobacco products1
- Compliance policy for required warning statements on small-packaged cigars1