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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters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

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

nlm:nlmuid-101734398-pdf

6. 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

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101712946-pdf

9. 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

10. 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

13. 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

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

nlm:nlmuid-101757549-pdf

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

nlm:nlmuid-101734070-pdf

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

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

nlm:nlmuid-101713299-pdf

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

nlm:nlmuid-101713430-pdf

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

nlm:nlmuid-101713302-pdf