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Titles
- 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
- 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
- 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
- Challenges to public health reporting experienced by non-federal acute care hospitals: 20191
- Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)1
- 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
- Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration 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
- Community-acquired bacterial pneumonia: developing drugs for treatment1
- Comparing outcomes for dual eligible beneficiaries in integrated care: final report1
- Competitive generic therapies1
- Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)1
- Considerations for building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities1