Titles
- Biodefense: federal efforts to develop biological threat awareness : report to Congressional requesters1
- Biological product deviation reporting for blood and plasma establishments1
- Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff1
- Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff1
- CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight1
- CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities1
- CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming1
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: developing drugs and biological products for treatment or prevention1
- Calculation of potential inflation-indexed rebates for Medicare Part B drugs1
- 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
- Care provider facilities described challenges addressing mental health needs of children in HHS custody1
- 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
- Centering fathers in human services programming to increase participation1
- Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff1