- Coast Guard health care: improvements needed for determining staffing needs and monitoring access to care : report to congressional committees1
- Collaborative agreements in health care: complexities, uncertainties, and considerations for oversight1
- Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry1
- Competitive generic therapies: guidance for industry1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry1
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff1
- Connecticut Medicaid Fraud Control Unit: 2021 inspection1
- Connecticut implemented our prior audit recommendations and generally complied with federal and state requirements for reporting and monitoring critical incidents1
- Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards1
- Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry1
- Contact tracing for air travel: CDC’s data system needs substantial improvement : report to congressional addressees1
- Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- Critical access hospitals: views on how Medicare payment and other factors affect behavioral health services : report to congressional committees1
- Cross labeling oncology drugs in combination regimens: guidance for industry1
- Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff1
- Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff1
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1