1. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy
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2. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications
3. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders
4. 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
5. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)
6. Q3C--tables and list
7. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards
8. M4E(R2): the CTD--efficacy
9. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)
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
11. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases
12. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments
13. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff
14. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff
15. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff
16. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff
17. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff
18. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter
19. 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
20. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter
21. 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
22. 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
23. 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
24. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter
25. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter
26. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter
27. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter
28. Health document submission requirements for tobacco products: (revised)
29. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)
30. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment
31. Regulatory classification of pharmaceutical co-crystals
32. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment
33. How to prepare a pre-request for designation (pre-RFD)
34. Migraine: developing drugs for acute treatment
35. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers
36. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)
37. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
38. E18 genomic sampling and management of genomic data
39. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool
40. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation
41. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population
42. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff
43. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff
44. Listing of ingredients in tobacco products: (revised)
45. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers
46. Special protocol assessment
47. Clinical trial imaging endpoint process standards
48. Assessing user fees under the Prescription Drug User Fee Amendments of 2017
49. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers
50. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act
51. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders
52. Acne vulgaris: establishing effectiveness of drugs intended for treatment
53. Bioanalytical method validation
54. Enforcement policy--OTC sunscreen drug products marketed without an approved application
55. Anthrax: developing drugs for prophylaxis of inhalational anthrax
56. Complicated intra-abdominal infections: developing drugs for treatment
57. Complicated urinary tract infections: developing drugs for treatment
58. Medical product communications that are consistent with the FDA-required labeling: questions and answers
59. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff
60. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff
61. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers
62. Assessing user fees under the biosimilar user fee amendments of 2017
63. ANDA submissions--amendments to abbreviated new drug applications under GDUFA
64. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components
65. E17 general principles for planning and design of multiregional clinical trials
66. Use of electronic health record data in clinical investigations
67. Labeling for biosimilar products
68. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases
69. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)
70. Elemental impurities in drug products
71. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances
72. Quality attribute considerations for chewable tablets
73. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations
74. Physiologically based pharmacokinetic analyses--format and content
75. Allergic rhinitis: developing drug products for treatment
76. Nonallergic rhinitis: developing drug products for treatment
77. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff
78. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff
79. Advancement of emerging technology applications for pharmaceutical innovation and modernization
80. Compliance policy for required warning statements on small-packaged cigars
81. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff
82. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff
83. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff
84. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff
85. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff
86. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
87. The prohibition of distributing free samples of tobacco products
88. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff
89. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff
90. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff
91. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff
92. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff
93. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice
94. Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery
95. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment
96. Recurrent herpes labialis: developing drugs for treatment and prevention
97. Evaluating drug effects on the ability to operate a motor vehicle
98. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff
99. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception
100. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff
