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16,257 results
  1. NLM Digital Collections - Safer technologies program for medical devices : guidance for industry and Food and Drug ... 
    Publication: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
    ... in STeP that are intending to address the same safety issue or improvement. As a consequence, multiple regulatory submissions for devices intending to address the same safety issue may be pending simultaneously. FDA recommends that ...
  2. ... devices Preventing extinguish- ment of Are, etc. Liability Same 528 HEALTH AND SAFETY CODE Payment of costs 13009. The expenses of ... Fire Advisory Board Qualifi- cations Quorum Chairman Meetings Same 538 HEALTH AND SAFETY CODE Records 13141.2. All records of the ...
  3. NLM Digital Collections - FDA oversight 
    Publication: [Toronto, Ontario] : Thomson Reuters, 20-December-2021
    ... reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would ... criteria specified by law. Patients can expect the same safety and effectiveness from the biosimilar over the course ...
  4. ... Weights and stresses Wooden studs: Dimensions Fire stopping Same HEALTH AND SAFETY CODE 543 17263. Each wooden stud wall and ... containers of such Partitions Same Paint shop, etc. Same HEALTH AND SAFETY CODE 553 materials, with an aggregate capacity not ...
  5. NLM Digital Collections - Generic drug development : stakeholders’ views of risk evaluation and mitigation strategies ... 
    Publication: Washington, DC : United States Government Accountability Office, October 2019
    ... FDA, although the generic company must meet the same safety level for the ETASU measures as those applied ... Source: GAO analysis of interviews with drug companies. │ same protections. The safety letter would also note that FDA would GAO- ...
  6. NLM Digital Collections - Text book (Volume 1) 
    Publication: St. Louis, Missouri : U.S. Army Medical Supply Services School, 1943-1944
    ... rating, providing the various companies operate on the same safety factor. If a tube of one manufacturer is ... such characteristics as are essential to maintain the same electrical margin of safety as would exist if the equipment were operated ...
  7. NLM Digital Collections - ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs .... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
    ... rDNA origin can be expected to have the same safety profile (including with respect to the risk of ... and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions ...
  8. NLM Digital Collections - A dictionary of arts and sciences (Volume 2) 
    Publication: Philadelphia : Published by Isaac Peirce ..., 1815-1816
    ... into his head, and lodging them in the same safety within his body. We have a very beau- ... I am enabled to judge, it may with safety be prepared by pouring 3 drachms of sulphuric acid, diluted with the same quantity of water upon 50 grains ofthe powder, ...
  9. NLM Digital Collections - Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide : backwards and forwards ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
    ... be used to distinguish the evolution of the same safety report over time. In E2B(R3), this distinction ... the E2B(R3) field E.i.3.1 (same values). 2) The E2B(R2) fields for seriousness criteria, stored at the safety report level, i.e., A.1.5.2, ...
  10. ... Similar Rates of Adverse Safety Events at the Same Hospital? Patient safety is “freedom from accidental injury due to medical ... patient RATES OF ADVERSE SAFETY EVENTS IN THE SAME HOSPITAL 5 safety to be drawn among patients admitted to the ...
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