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2. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

nlm:nlmuid-101713206-pdf

3. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

nlm:nlmuid-101713330-pdf

4. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

nlm:nlmuid-101734398-pdf

5. Considerations for the development of dried plasma products intended for transfusion

nlm:nlmuid-101760572-pdf

6. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101759953-pdf

8. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

nlm:nlmuid-101734304-pdf

9. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

nlm:nlmuid-101712951-pdf

10. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

nlm:nlmuid-101712946-pdf

11. Evaluation of devices used with regenerative medicine advanced therapies

nlm:nlmuid-101760001-pdf

12. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

nlm:nlmuid-101760391-pdf

13. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

nlm:nlmuid-101712948-pdf

14. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

nlm:nlmuid-101713196-pdf

15. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

nlm:nlmuid-101746273-pdf

16. Health document submission requirements for tobacco products: (revised)

nlm:nlmuid-101733958-pdf

17. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

nlm:nlmuid-101760029-pdf

18. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

nlm:nlmuid-101760537-pdf

19. Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees

nlm:nlmuid-101727012-pdf

20. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

nlm:nlmuid-101719844-pdf

22. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

nlm:nlmuid-101760101-pdf

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

nlm:nlmuid-101757549-pdf

26. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

nlm:nlmuid-101734070-pdf

27. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

nlm:nlmuid-101713272-pdf

28. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

nlm:nlmuid-101713306-pdf

29. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

nlm:nlmuid-101713277-pdf

30. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

nlm:nlmuid-101713281-pdf

31. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

nlm:nlmuid-101713288-pdf

32. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

nlm:nlmuid-101713291-pdf

33. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

nlm:nlmuid-101713296-pdf

34. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

nlm:nlmuid-101713299-pdf

35. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

nlm:nlmuid-101713430-pdf

36. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

nlm:nlmuid-101713302-pdf

37. Quality attribute considerations for chewable tablets

nlm:nlmuid-101734404-pdf

39. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

nlm:nlmuid-101734357-pdf

42. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research

nlm:nlmuid-101760023-pdf