11. Real-time oncology review (RTOR): guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2023 Subject(s): Biological ProductsDrug ApprovalDrug IndustryDrugs, InvestigationalGovernment RegulationNeoplasms -- drug therapyUnited States
12. Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Antibodies, MonoclonalCOVID-19 Drug TreatmentDrug ApprovalDrug IndustryGovernment RegulationLegislation, DrugSARS-CoV-2United States
13. Memorandum from William H. Foege, Centers for Disease Control to C. Everett Koop Publication: Produced: 4 February 1983 Subject(s): Hepatitis B VaccinesGuillain-Barre SyndromeDrug ApprovalDrug Industry Archival Collection: The C. Everett Koop Papers (Profiles in Science)
14. Letter from C. Everett Koop to Diane L. Schweber Publication: Produced: 9 December 1982 Subject(s): Hepatitis B VaccinesGuillain-Barre SyndromeDrug ApprovalDrug Industry Archival Collection: The C. Everett Koop Papers (Profiles in Science)
15. Memorandum from Arthur Hull Hayes Jr., Food and Drug Administration to C. Everett Koop Publication: Produced: 6 January 1983 Subject(s): Hepatitis B VaccinesGuillain-Barre SyndromeDrug ApprovalDrug Industry Archival Collection: The C. Everett Koop Papers (Profiles in Science)
16. Memorandum from C. Everett Koop to William H. Foege, Centers for Disease Control and Arthur Hull Hayes Jr., Food and Drug Administration Publication: Produced: 9 December 1982 Subject(s): Drug ApprovalDrug IndustryGuillain-Barre SyndromeHepatitis B Vaccines Archival Collection: The C. Everett Koop Papers (Profiles in Science)
17. Letter from Diane L. Schweber to C. Everett Koop Publication: Produced: 22 November 1982 Subject(s): Drug ApprovalDrug IndustryGuillain-Barre SyndromeHepatitis B Vaccines Archival Collection: The C. Everett Koop Papers (Profiles in Science)
18. National women's health action at the F.D.A. Sept. 20, 1994 Publication: [United States : s.n.], 1994 Subject(s): Women's HealthDrug IndustryDrugs, InvestigationalDrug ApprovalUnited States. Food and Drug Administration.
