U.S. Department of Health & Human Services

NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Formats Text Remove constraint Formats: Text Collections Health Policy and Services Research Remove constraint Collections: Health Policy and Services Research Copyright Public domain Remove constraint Copyright: Public domain Subjects United States. Department of Health and Human Services. Remove constraint Subjects: United States. Department of Health and Human Services. Genre Technical Report Remove constraint Genre: Technical Report
Number of results to display per page

Search Results

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

nlm:nlmuid-101719973-pdf

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

nlm:nlmuid-101719981-pdf

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

nlm:nlmuid-101719987-pdf

125. 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

126. 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

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

nlm:nlmuid-101720001-pdf

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

nlm:nlmuid-101720003-pdf

132. 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

134. 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

138. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace

nlm:nlmuid-101737746-pdf

139. CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming

nlm:nlmuid-101737750-pdf