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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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24,468 rows where agency_id = "FDA" and posted_year = 2017 sorted by posted_date descending

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  • 2017 · 24,468 ✖

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  • FDA · 24,468 ✖
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2017-V-7020-0002 FDA FDA-2017-V-7020 Acknowledgment Letter from FDA DDM to W6 Restaurant Group LTD Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:38:57Z   0 0 0900006482d83ab8
FDA-2017-H-6960-0001 FDA FDA-2017-H-6960 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:59:43Z   0 0 0900006482d84c25
FDA-1994-P-0028-0047 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T16:45:07Z   0 0 09000064804fd363
FDA-2017-P-7032-0003 FDA FDA-2017-P-7032 Exhibit 1 Electronic Orange Book re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:48:54Z   0 0 0900006482d84ab7
FDA-2017-P-7034-0003 FDA FDA-2017-P-7034 Exhibit 1 Orange Book Listing re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:20Z   0 0 0900006482d84d72
FDA-2017-P-7034-0005 FDA FDA-2017-P-7034 Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:46Z   0 0 0900006482d84d74
FDA-2017-P-7032-0005 FDA FDA-2017-P-7032 Exhibit 3 Draft Labeling for proposed product re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:49:28Z   0 0 0900006482d84aba
FDA-2017-H-6973-0001 FDA FDA-2017-H-6973 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T19:30:07Z   0 0 0900006482d84ca5
FDA-2017-V-7020-0001 FDA FDA-2017-V-7020 Variance Application from W6 Restaurant Group LTD Other Application for Variance (VAR) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:38:51Z   0 0 0900006482d83ab6
FDA-2017-P-7031-0002 FDA FDA-2017-P-7031 Acknowledgment Letter from FDA DDM to JRRapoza Associates, Inc Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T17:34:05Z   0 0 0900006482d8388f
FDA-2017-P-7032-0001 FDA FDA-2017-P-7032 Citizen Petition from Jubilant Generics Limited Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2018-01-02T16:48:06Z   0 0 0900006482d843bf
FDA-2017-V-7023-0001 FDA FDA-2017-V-7023 Variance Application from Platinum AVL Other Application for Variance (VAR) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:37:20Z   0 0 0900006482d83c59
FDA-2017-P-7033-0004 FDA FDA-2017-P-7033 Exhibit 2 RLD Label re Citizen Petition from Jubliant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:51:33Z   0 0 0900006482d84da8
FDA-2017-P-7033-0006 FDA FDA-2017-P-7033 Exhibit 4 Oxetol Dosage & Drug Information re Citizen Petition from Jubliant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:51:56Z   0 0 0900006482d84daa
FDA-1977-N-0025-0008 FDA Internal, Analgesic, Antipyretic & Antirheumatic Drug Products - OPEN FDA-1977-N-0025 Literature References re: Supplement from Wyeth Consumer Healthcare Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2019-02-04T14:04:52Z   0 0 09000064805da2fa
FDA-1977-N-0025-0007 FDA Internal, Analgesic, Antipyretic & Antirheumatic Drug Products - OPEN FDA-1977-N-0025 Supplement from Wyeth Consumer Healthcare Other Supplement (SUP) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2019-02-01T15:40:00Z   0 0 09000064805da2f9
FDA-2017-H-6986-0001 FDA FDA-2017-H-6986 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T20:05:43Z   0 0 0900006482d85162
FDA-2017-V-7021-0002 FDA FDA-2017-V-7021 Acknowledgment Letter from FDA DDM to Trio Nightclub Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:41:48Z   0 0 0900006482d83abe
FDA-2014-P-0646-0011 FDA FDA-2014-P-0646 Letter from Kamat Pharmatech to FDA DDM Other Letter(s) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:42:48Z   0 0 0900006482d8388b
FDA-2017-P-7032-0002 FDA FDA-2017-P-7032 Acknowledgment Letter from FDA DDM to Jubilant Generics Limited Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2018-01-02T16:48:30Z   0 0 0900006482d843c1
FDA-2017-H-6948-0001 FDA FDA-2017-H-6948 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:48:22Z   0 0 0900006482d84e08
FDA-1994-P-0028-0046 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T16:44:36Z   0 0 09000064804fd353
FDA-2017-P-7033-0001 FDA FDA-2017-P-7033 Citizen Petition from Jubliant Generics Limited Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2018-01-02T16:50:17Z   0 0 0900006482d84d79
FDA-2017-H-6958-0001 FDA FDA-2017-H-6958 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:54:54Z   0 0 0900006482d84e3e
FDA-2017-H-6952-0001 FDA FDA-2017-H-6952 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:47:45Z   0 0 0900006482d84e02
FDA-2017-D-6530-0002 FDA FDA-2017-D-6530 Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry DRAFT GUIDANCE Other Guidance 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-03-30T03:59:59Z 2024-11-07T01:15:37Z   1 0 0900006482d7eb25
FDA-2017-D-6564-0002 FDA FDA-2017-D-6564 Best Practices for Communication Between IND Sponsors and FDA During Drug Development Guidance for Industry and Review Staff Other Guidance 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2024-11-07T01:15:37Z   1 0 0900006482d7eb23
FDA-2017-P-7031-0003 FDA FDA-2017-P-7031 Attachment 1 Orange Book Listing re Citizen Petition from JRRapoza Associates, Inc Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T17:34:25Z   0 0 0900006482d83891
FDA-2017-P-7033-0002 FDA FDA-2017-P-7033 Acknowledgment Letter from FDA DDM to Jubilant Generics Limited Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2018-01-02T16:50:45Z   0 0 0900006482d84da4
FDA-2017-P-7034-0001 FDA FDA-2017-P-7034 Citizen Petition from Jubilant Generics Limited Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2018-01-02T16:52:40Z   0 0 0900006482d84d2a
FDA-2017-P-7031-0001 FDA FDA-2017-P-7031 Citizen Petition from JRRapoza Associates, Inc Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2017-12-29T17:33:49Z   0 0 0900006482d8388d
FDA-2017-P-7032-0004 FDA FDA-2017-P-7032 Exhibit 2 RLD Labeling re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:49:10Z   0 0 0900006482d84ab8
FDA-2017-P-7034-0006 FDA FDA-2017-P-7034 Exhibit 4 Valtrex Tablets 250 mg re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:57Z   0 0 0900006482d84d75
FDA-2017-P-7031-0004 FDA FDA-2017-P-7031 Attachment 2 Approved Drug Labeling RLD re Citizen Petition from JRRapoza Associates, Inc Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T17:34:41Z   0 0 0900006482d84574
FDA-2017-D-6564-0001 FDA FDA-2017-D-6564 Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability Notice Notice of Availability 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T14:28:34Z 2017-28139 0 0 0900006482d832c0
FDA-2017-D-6530-0001 FDA FDA-2017-D-6530 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-03-30T03:59:59Z 2018-03-28T01:02:41Z 2017-28140 0 0 0900006482d832bd
FDA-2016-N-0832-0057 FDA FDA-2016-N-0832 Letter from Phibro Animal Health Corporation Other Letter(s) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T15:57:53Z   0 0 0900006482d83a18
FDA-2017-V-7023-0002 FDA FDA-2017-V-7023 Acknowledgement Letter from FDA DDM to Platinum AVL Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:37:25Z   0 0 0900006482d83c5c
FDA-2017-P-7033-0003 FDA FDA-2017-P-7033 Exhibit 1 Orange Book Listing re Citizen Petition from Jubliant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:51:21Z   0 0 0900006482d84da7
FDA-2017-P-7033-0005 FDA FDA-2017-P-7033 Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubliant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:51:45Z   0 0 0900006482d84da9
FDA-2017-V-7028-0002 FDA FDA-2017-V-7028 Acknowledgement Letter from FDA DDM to Richard Nguyen Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:19:48Z   0 0 0900006482d84abf
FDA-2017-H-6963-0001 FDA FDA-2017-H-6963 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T19:24:17Z   0 0 0900006482d84efa
FDA-2017-P-7034-0004 FDA FDA-2017-P-7034 Exhibit 2 RLD Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:34Z   0 0 0900006482d84d73
FDA-2017-P-7034-0002 FDA FDA-2017-P-7034 Acknowledgment Letter from FDA DDM to Jubilant Generics Limited Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2018-01-02T16:53:05Z   0 0 0900006482d84d2c
FDA-2017-H-6953-0001 FDA FDA-2017-H-6953 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:45:41Z   0 0 0900006482d84e38
FDA-2017-V-7021-0001 FDA FDA-2017-V-7021 Variance Application from Trio Nightclub Other Application for Variance (VAR) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T16:41:43Z   0 0 0900006482d83abc
FDA-2017-V-7028-0001 FDA FDA-2017-V-7028 Variance Application from RICHARD NGUYEN Other Application for Variance (VAR) 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T18:19:42Z   0 0 0900006482d837cd
FDA-2017-H-6972-0001 FDA FDA-2017-H-6972 Complaint Other Complaint 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2017-12-29T19:11:59Z   0 0 0900006482d84ef4
FDA-1977-N-0025-0009 FDA Internal, Analgesic, Antipyretic & Antirheumatic Drug Products - OPEN FDA-1977-N-0025 Mail Slip re: Supplement from Wyeth Consumer Healthcare Supporting & Related Material Transmittals 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2019-02-04T14:03:07Z   0 0 09000064805da2fb
FDA-1980-N-0038-0121 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Evaluation of a Topical Steroid Antibiotic Combination (Halcinonide-Neomycin-Amphotericin) in the Treatment of Cutaneous Candidiasis and Inflammatory Dermatoses re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:56:50Z   0 0 09000064805b9631
FDA-1980-N-0038-0138 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin and Hydrocortisone) Request of CIBA-GEIGY Corporation for Hearing Vol I re: Supplement from CIBA-GEIGY (Wald, Harkrader & Ross) (Vol 1 of 3) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:11:59Z   0 0 09000064805b963e
FDA-2017-P-4039-0003 FDA FDA-2017-P-4039 Interim Response Letter from FDA CDER to Center for Lawful Access and Abuse Deterrence Other Letter(s) 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T21:28:04Z   0 0 0900006482d7f298
FDA-2005-D-0140-0012 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 1 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,” Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:42Z   0 0 0900006482d7ee3f
FDA-2005-D-0140-0015 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 4 Busch MP. Closing the windows on viral transmission by blood transfusion. In Stramer SL ed. Blood Safety in the New Millenium. Bethesda, MD: American Association of Blood Banks, 2001: Chapter 2, p.36. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:28Z   0 0 0900006482d7ee42
FDA-1980-N-0038-0150 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 3 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:03Z   0 0 0900006482cd5c29
FDA-2015-V-0429-0003 FDA FDA-2015-V-0429 Approval Letter from FDA CDRH to Power Technology, Inc. Other Approval for Variance (VRA) 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T15:21:49Z   0 0 0900006482d7b398
FDA-2017-H-6956-0001 FDA FDA-2017-H-6956 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T15:55:12Z   0 0 0900006482d7b912
FDA-2017-H-6957-0001 FDA FDA-2017-H-6957 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T18:31:50Z   0 0 0900006482d7c0f5
FDA-2017-H-6954-0001 FDA FDA-2017-H-6954 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T15:25:41Z   0 0 0900006482d7b39a
FDA-2017-H-6962-0001 FDA FDA-2017-H-6962 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T19:21:49Z   0 0 0900006482d7db54
FDA-2001-N-0437-0003 FDA CGMP Regulations for Medicated Feeds-Closed FDA-2001-N-0437 Supporting Statement - The Current Good Manufacturing Practice for Medicated Feeds Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2024-11-25T16:34:48Z   0 0 09000064804e8893
FDA-2005-D-0140-0010 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry Other Guidance 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2024-11-07T01:15:24Z   1 0 0900006482d7ee3c
FDA-2005-D-0140-0016 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 5 Glynn SA, Kleinman SH, Wright DJ, Busch MP. International application of the incidence rate/window period model. Transfusion 42:966-972 (2002). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:23Z   0 0 0900006482d7ee43
FDA-2017-H-6965-0001 FDA FDA-2017-H-6965 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T19:25:13Z   0 0 0900006482d7e13f
FDA-2005-D-0140-0022 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 11 Alter HJ. To C or not to C: These are the questions. Blood 85:1681-1695 (1995). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:39:54Z   0 0 0900006482d7ee52
FDA-2005-D-0140-0011 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 001 - List of References - Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry Guidance for Industry Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:50Z   0 0 0900006482d7ee3e
FDA-2005-D-0140-0021 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 10 Blood Products Advisory Committee, 69th Meeting, June 14, 2001 Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:39:59Z   0 0 0900006482d7ee51
FDA-1980-N-0038-0156 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Request for Hearing from Clay-Park Labs, Inc. Other Request for Hearing 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:23:17Z   0 0 09000064805b964a
FDA-1980-N-0038-0141 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from Miles Laboratories, Inc. to FDA/DDM Other Letter(s) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:13:51Z   0 0 09000064805b963f
FDA-1980-N-0038-0122 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Clinical Evaluation of a New Halcinonide-Antifungal Combination re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:57:25Z   0 0 09000064805b9632
FDA-1980-N-0038-0120 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Combined Steroid-Antiinfective Topical Therapy in Common Dermatoses A Double- Blind, Multi-Center Study of Iodochlorhydroxyquin-Hydrocortisone in 277 Patients re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:55:20Z   0 0 09000064805b9630
FDA-2005-D-0140-0019 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 8 Federal Register, December 14, 1999 (64 FR 71147), Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2, December 1999. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:08Z   0 0 0900006482d7ee4f
FDA-2005-D-0140-0020 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 9 Federal Register, August 24, 2007 (72 FR 48765), Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”); Final Rule. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:03Z   0 0 0900006482d7ee50
FDA-2001-N-0437-0004 FDA CGMP Regulations for Medicated Feeds-Closed FDA-2001-N-0437 Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds Notice Notice of Approval 2017-12-28T05:00:00Z 2017 12     2024-11-25T16:30:52Z 01–25763 0 0 09000064804e8894
FDA-1980-N-0038-0153 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Answer Letter from Arthur Hull Hayes, Jr. to American Academy of Dermatology, Inc. Other Answer 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:21:20Z   0 0 09000064805b9647
FDA-1980-N-0038-0155 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Letter from Linda M. Quinones to American Academy of Dermatology, Inc. Other Letter(s) 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:22:12Z   0 0 09000064805b9649
FDA-1980-N-0038-0128 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin-Hydrocortisone Treatment of Fungal Infections re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:00:02Z   0 0 09000064805b9638
FDA-1980-N-0038-0148 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 1 of 5) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:40Z   0 0 09000064805b9646
FDA-1980-N-0038-0152 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 5 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:25Z   0 0 0900006482cd4ff8
FDA-1980-N-0038-0151 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Burroughs Wellcome Co. (Vol. 4 of 5) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T19:19:13Z   0 0 0900006482cd5304
FDA-2017-N-6778-0001 FDA FDA-2017-N-6778 Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program Notice Announcement 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T14:57:25Z 2017-28044 0 0 0900006482d7a81e
FDA-2005-D-0140-0018 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 7 Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of HIV-1 viremia and antibody seroconversion in plasma donors: Implications for diagnosis and staging of primary HIV-1 infection. AIDS 17:1871-1879 (2003). Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:13Z   0 0 0900006482d7ee4e
FDA-1980-N-0038-0133 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Merck Sharp & Dohme Research Labs (Vol. 1 of 4) Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:05:18Z   0 0 09000064805b963c
FDA-1980-N-0038-0142 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Withdrawal Letter from Miles Laboratories, Inc. Other Withdrawal 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:19:41Z   0 0 09000064805b9640
FDA-2017-H-6964-0001 FDA FDA-2017-H-6964 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T19:23:34Z   0 0 0900006482d7db87
FDA-2017-V-6985-0001 FDA FDA-2017-V-6985 Variance Application from Aka Booking Agency Other Application for Variance (VAR) 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T15:15:52Z   0 0 0900006482d73063
FDA-2001-N-0437-0002 FDA CGMP Regulations for Medicated Feeds-Closed FDA-2001-N-0437 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds Notice 30 Day Proposed Information Collection 2017-12-28T05:00:00Z 2017 12 2001-06-15T04:00:00Z 2001-07-17T03:59:59Z 2024-11-25T16:25:48Z 01-15081 0 0 09000064804e8892
FDA-2017-H-6966-0001 FDA FDA-2017-H-6966 Complaint Other Complaint 2017-12-28T05:00:00Z 2017 12 2017-12-28T05:00:00Z   2017-12-28T19:32:32Z   0 0 0900006482d7e147
FDA-1980-N-0038-0147 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Mayrand, Inc. Pharmaceuticals Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:39Z   0 0 09000064805b9645
FDA-1980-N-0038-0145 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from UAD Laboratories, Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T06:55:40Z   0 0 09000064805b9643
FDA-2005-D-0140-0014 FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry;' FDA-2005-D-0140 Reference 3 FDA Memorandum to All Registered Blood Establishments: “Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),” August 5, 1993. Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T20:40:33Z   0 0 0900006482d7ee41
FDA-1980-N-0038-0123 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorhydroxyquin re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:58:13Z   0 0 09000064805b9633
FDA-1980-N-0038-0124 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Topical Vioform-Hydrocortisone in Varicose Ulcer re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:58:38Z   0 0 09000064805b9634
FDA-1980-N-0038-0119 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from National Pharmaceutical Alliance Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:02:14Z   0 0 09000064805b962f
FDA-1980-N-0038-0131 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Iodochlorohydroxyquinoline (Vioform) Hydrocortisone Cream and Lotion in Superficial Fungus Infections re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:02:02Z   0 0 09000064805b963b
FDA-1980-N-0038-0143 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Correction from the Lemmon Company Other Correction(s) 2017-12-28T05:00:00Z 2017 12     2018-01-02T20:45:08Z   0 0 09000064805b9641
FDA-1980-N-0038-0140 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin and Hydrocortisone) Request of CIBA-GEIGY Corporation for Hearing Vol II re: Supplement from CIBA-GEIGY (Wald, Harkrader & Ross) (Vol. 3 of 3) Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:12:50Z   0 0 0900006482ceabb3
FDA-1980-N-0038-0125 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Management of Chronic Eczematoid Dermatitis of the Hands re: Supplement from National Pharmaceutical Alliance Supporting & Related Material Background Material 2017-12-28T05:00:00Z 2017 12     2017-12-28T17:59:02Z   0 0 09000064805b9635
FDA-1980-N-0038-0137 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 The Proposal to Withdraw the New Drug Application for Terra-Cortril Topical Ointment (NDA 61-011, Section 446.567(a)) - Submission of Data for Terra-Cortril Topical Ointment re Supplement from Pfizer Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2017-12-28T18:11:19Z   0 0 09000064805b963d
FDA-1980-N-0038-0144 FDA Anti-Infective Drug Products for Dermatologic Use FDA-1980-N-0038 Supplement from Marnel Pharmaceuticals, Inc. Other Supplement (SUP) 2017-12-28T05:00:00Z 2017 12     2020-01-31T07:27:06Z   0 0 09000064805b9642

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