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

nlm:nlmuid-101719888-pdf

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

nlm:nlmuid-101719889-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101719926-pdf

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

nlm:nlmuid-101719954-pdf

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

nlm:nlmuid-101719973-pdf

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

nlm:nlmuid-101719981-pdf

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

nlm:nlmuid-101719987-pdf

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

nlm:nlmuid-101719989-pdf

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

nlm:nlmuid-101719990-pdf

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

nlm:nlmuid-101720001-pdf

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

nlm:nlmuid-101720003-pdf

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

nlm:nlmuid-101720038-pdf

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

nlm:nlmuid-101720053-pdf

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

nlm:nlmuid-101516785-pdf

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

nlm:nlmuid-101628683-pdf

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

nlm:nlmuid-101738136-pdf

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

nlm:nlmuid-101740174-pdf

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

nlm:nlmuid-101656652-pdf

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

nlm:nlmuid-101746066-pdf

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

nlm:nlmuid-101746132-pdf