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Titles
- S12 nonclinical biodistribution considerations for gene therapy products: guidance for industry1
- S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry1
- Scientific integrity: HHS agencies need to develop procedures and train staff on reporting and addressing political interference : report to congressional addressees1
- Scientific integrity: HHS agencies need to develop procedures and train staff on reporting and addressing political interference : testimony before the Select Subcommittee on the Coronavirus Crisis, Committee on Oversight and Reform, House of Representatives1
- Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry1
- Smoking cessation and related indications: developing nicotine replacement therapy drug products : guidance for industry1
- Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff1
- Some Medicare Advantage Organization denials of prior authorization requests raise concerns about beneficiary access to medically necessary care1
- Some skin substitute manufacturers did not comply with new ASP reporting requirements1
- South Dakota MMIS and E&E system security controls were partially effective and improvements are needed1
- States face ongoing challenges in meeting third-party liability requirements for ensuring that Medicaid functions as the payer of last resort1
- Strengthening the integrated care workforce1
- Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry1
- Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document1
- Submitting documents using real-world data and real-world evidence to FDA for drug and biological products1
- Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document1
- Suicide prevention: DOD should enhance oversight, staffing, guidance, and training affecting certain remote installations : report to congressional committees1
- Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff1