Titles
- Assessing user fees under the biosimilar user fee amendments of 20171
- Assessment and synthesis of selected Medicaid eligibility, enrollment, and renewal processes and systems in six states1
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion1
- Bacterial vaginosis: developing drugs for treatment1
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Bioanalytical method validation1
- Biodefense: federal efforts to develop biological threat awareness : report to Congressional requesters1
- 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
- Calculation of potential inflation-indexed rebates for Medicare Part B drugs1
- Care provider facilities described challenges addressing mental health needs of children in HHS custody1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Challenges appear to limit states' use of Medicaid payment suspensions1
- 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
- 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