U.S. Department of Health & Human Services

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102. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff


103. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff


106. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment


107. Recurrent herpes labialis: developing drugs for treatment and prevention


109. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff


110. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception


112. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products


113. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff


114. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry


115. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff


116. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff


117. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components


121. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system


123. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff


127. Physician assistants and nurse practitioners in specialty care: six practices make it work


128. Measuring up?: end-of-life cancer care in California


133. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices


134. Snapshots of recent state initiatives in Medicaid prescription drug cost control


135. A sense of déjà vu: the debate surrounding state biosimilar substitution laws


136. Imported seafood safety: FDA and USDA could strengthen efforts to prevent unsafe drug residues : report to the chairman, Committee on Appropriations, U.S. Senate


137. Low-dose radiation: interagency collaboration on planning research could improve information on health effects : testimony before the Subcommittee on Energy, Committee on Science, Space, and Technology, House of Representatives


145. Keeping America's food safe: a blueprint for fixing the food safety system at the U.S. Department of Health and Human Services


146. One percent of drugs with Medicaid reimbursement were not FDA-approved