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

nlm:nlmuid-101759953-pdf

7. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101759974-pdf

10. Opioid use disorder: developing depot buprenorphine products for treatment

nlm:nlmuid-101759999-pdf

11. Evaluation of devices used with regenerative medicine advanced therapies

nlm:nlmuid-101760001-pdf

12. Considerations for the inclusion of adolescent patients in adult oncology clinical trials

nlm:nlmuid-101760009-pdf

13. Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals

nlm:nlmuid-101760012-pdf

14. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

nlm:nlmuid-101760015-pdf

15. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760016-pdf

16. Pediatric HIV infection: drug product development for treatment

nlm:nlmuid-101760019-pdf

17. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis

nlm:nlmuid-101760020-pdf

18. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

nlm:nlmuid-101760022-pdf

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

nlm:nlmuid-101760023-pdf

20. Pediatric information incorporated into human prescription drug and biological product labeling

nlm:nlmuid-101760024-pdf

21. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760027-pdf

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

nlm:nlmuid-101760029-pdf

23. REMS: FDA's application of statutory factors in determining when a REMS is necessary

nlm:nlmuid-101760030-pdf

24. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

nlm:nlmuid-101760038-pdf

25. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

nlm:nlmuid-101760039-pdf

26. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760040-pdf

27. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760046-pdf

28. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760051-pdf

29. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760055-pdf

30. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760057-pdf

31. Policy clarification for certain fluoroscopic equipment requirements: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760060-pdf

32. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760064-pdf

33. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760067-pdf

34. Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk

nlm:nlmuid-101760073-pdf

35. Recommendations for reducing the risk of transfusion-transmitted babesiosis

nlm:nlmuid-101760087-pdf

37. 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

38. Oncology pharmaceuticals: reproductive toxicity testing and labeling recommendations

nlm:nlmuid-101760106-pdf

39. Considerations in demonstrating interchangeability with a reference product

nlm:nlmuid-101760108-pdf

40. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

nlm:nlmuid-101760231-pdf

41. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

nlm:nlmuid-101760238-pdf

42. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

nlm:nlmuid-101760248-pdf

43. Premarket tobacco product applications for electronic nicotine delivery systems

nlm:nlmuid-101760254-pdf

44. Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760255-pdf

46. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

nlm:nlmuid-101760257-pdf

47. Delayed graft function in kidney transplantation: developing drugs for prevention

nlm:nlmuid-101760258-pdf

49. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

nlm:nlmuid-101760271-pdf

50. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff

nlm:nlmuid-101760276-pdf