- CT contrast media power injectors can rupture conventional IV sets1
- Cancer clinical trial eligibility criteria: brain metastases1
- Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs1
- Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections1
- Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies1
- Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff1
- Challenges remain in FDA's inspections of domestic food facilities1
- 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