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70 rows where docket_id = "FDA-2015-N-2002" sorted by posted_date descending
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document_type 4
- Supporting & Related Material 50
- Other 10
- Rule 6
- Proposed Rule 4
agency_id 1
- FDA 70
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2015-N-2002-2054 | FDA | None FDA-2015-N-2002 | Regulations Regarding ‘‘Intended Uses’’ | Rule | Final Rule | 2021-08-02T04:00:00Z | 2021 | 8 | 2021-08-02T04:00:00Z | 2021-08-02T16:56:29Z | 2021-15980 | 0 | 0 | 0900006484c2027a | |
| FDA-2015-N-2002-2038 | FDA | None FDA-2015-N-2002 | Request for Extension from Medical Information Working Group (MIWG) | Other | Request for Extension | 2020-12-15T05:00:00Z | 2020 | 12 | 2020-12-15T05:00:00Z | 2020-12-15T22:20:25Z | 0 | 0 | 09000064848b8379 | ||
| FDA-2015-N-2002-2037 | FDA | None FDA-2015-N-2002 | Request for Extension from Advanced Medical Technology Association (AdvaMed) | Other | Request for Extension | 2020-12-15T05:00:00Z | 2020 | 12 | 2020-12-15T05:00:00Z | 2020-12-15T22:18:20Z | 0 | 0 | 09000064848a3295 | ||
| FDA-2015-N-2002-2036 | FDA | None FDA-2015-N-2002 | Intended Use PR - Response to MIWG Request to Extend Comment Period | Other | Letter(s) | 2020-11-17T05:00:00Z | 2020 | 11 | 2020-11-17T05:00:00Z | 2020-11-17T15:01:04Z | 0 | 0 | 09000064849619c9 | ||
| FDA-2015-N-2002-2035 | FDA | None FDA-2015-N-2002 | Intended Use PR - Response to AdvaMed Request to Extend Comment Period | Other | Letter(s) | 2020-11-17T05:00:00Z | 2020 | 11 | 2020-11-17T05:00:00Z | 2020-11-17T15:00:53Z | 0 | 0 | 09000064849619c7 | ||
| FDA-2015-N-2002-2031 | FDA | None FDA-2015-N-2002 | REFERENCE 1 - Plaintiff’s Memorandum of Law at 38–40, Allergan Inc. v. United States RE Regulations Regarding Intended Uses | Supporting & Related Material | Background Material | 2020-09-23T04:00:00Z | 2020 | 9 | 2020-09-23T16:38:10Z | 0 | 0 | 0900006484873dc9 | |||
| FDA-2015-N-2002-2034 | FDA | None FDA-2015-N-2002 | REFERENCE 10 - Eguale, T., D.L. Buckeridge, A. Verma, et al RE Regulations Regarding Intended Uses | Supporting & Related Material | Background Material | 2020-09-23T04:00:00Z | 2020 | 9 | 2020-09-23T16:38:36Z | 0 | 0 | 0900006484873f3b | |||
| FDA-2015-N-2002-2032 | FDA | None FDA-2015-N-2002 | REFERENCE 2 - Complaint at 35–37, Par Pharmaceutical Inc. v. United States RE Regulations Regarding Intended Uses | Supporting & Related Material | Background Material | 2020-09-23T04:00:00Z | 2020 | 9 | 2020-09-23T16:38:19Z | 0 | 0 | 0900006484873dca | |||
| FDA-2015-N-2002-2030 | FDA | None FDA-2015-N-2002 | Regulations Regarding Intended Uses | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2020-09-23T04:00:00Z | 2020 | 9 | 2020-09-23T04:00:00Z | 2020-10-24T03:59:59Z | 2020-12-16T02:02:47Z | 2020-20437 | 0 | 0 | 0900006484872e2d |
| FDA-2015-N-2002-2033 | FDA | None FDA-2015-N-2002 | REFERENCE 3 - Citizen Petition from the Medical Information Working Group at 18 RE Regulations Regarding Intended Uses | Supporting & Related Material | Background Material | 2020-09-23T04:00:00Z | 2020 | 9 | 2020-09-23T16:38:27Z | 0 | 0 | 0900006484873dcb | |||
| FDA-2015-N-2002-2029 | FDA | None FDA-2015-N-2002 | Kalb et al_IU Final Rule_Response_3-26-18 | Other | Agency Response | 2018-04-09T04:00:00Z | 2018 | 4 | 2018-04-09T04:00:00Z | 2018-04-09T21:10:24Z | 0 | 0 | 09000064830e95e3 | ||
| FDA-2015-N-2002-2028 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Partial Delay of Effective Date | Rule | Final Rule | 2018-03-16T04:00:00Z | 2018 | 3 | 2018-03-16T04:00:00Z | 2018-03-16T14:18:37Z | 2018-05347 | 0 | 0 | 090000648301bfb5 | |
| FDA-2015-N-2002-2008 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Proposed Partial Delay of Effective Date | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2018-01-16T05:00:00Z | 2018 | 1 | 2018-01-16T05:00:00Z | 2018-02-06T04:59:59Z | 2018-02-06T14:02:16Z | 2018-00555 | 0 | 0 | 0900006482e0b3c7 |
| FDA-2015-N-2002-2005 | FDA | None FDA-2015-N-2002 | Petition Interim Response from FDA OP to MIWG | Other | Letter(s) | 2017-08-01T04:00:00Z | 2017 | 8 | 2017-08-01T04:00:00Z | 2017-08-01T14:11:37Z | 0 | 0 | 090000648299066a | ||
| FDA-2015-N-2002-1990 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Further Delayed Effective Date; Request for Comments; Extension of Comment Period | Rule | Extension of Comment Period | 2017-05-18T04:00:00Z | 2017 | 5 | 2017-05-18T04:00:00Z | 2017-07-19T03:59:59Z | 2017-07-19T01:01:40Z | 2017-10036 | 0 | 0 | 09000064825dcd61 |
| FDA-2015-N-2002-1988 | FDA | None FDA-2015-N-2002 | Request for Extension from MIWG, PhRMA, and BIO | Other | Request for Extension | 2017-04-05T04:00:00Z | 2017 | 4 | 2017-04-05T04:00:00Z | 2017-04-05T20:52:17Z | 0 | 0 | 090000648253db32 | ||
| FDA-2015-N-2002-1981 | FDA | None FDA-2015-N-2002 | Reference 1 United States v. LA Rush, 213-cr-00249, First Superseding Information (C.D. Cal. April 3, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:11:06Z | 0 | 0 | 090000648250ead8 | |||
| FDA-2015-N-2002-1987 | FDA | None FDA-2015-N-2002 | Reference 7 DOJ_Atlanta Man Convicted of Illegally Importing and Distributing Male Enhancement Products from China re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:20:58Z | 0 | 0 | 090000648250ef2e | |||
| FDA-2015-N-2002-1983 | FDA | None FDA-2015-N-2002 | Reference 3 United States v. Carlson, 12-cr-00305-DSD-LIB, Court’s Instructions to the Jury, (D. Minn. Oct. 8, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:13:17Z | 0 | 0 | 090000648250eada | |||
| FDA-2015-N-2002-1979 | FDA | None FDA-2015-N-2002 | Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Rule | Delay of Effective Date | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T04:00:00Z | 2017-05-20T03:59:59Z | 2017-05-20T01:00:19Z | 2017-05526 | 0 | 0 | 090000648251322d |
| FDA-2015-N-2002-1984 | FDA | None FDA-2015-N-2002 | Reference 4 United States v. Bowen, 14-cr-00169-PAB, Indictment (D. Colo. May 5, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:14:17Z | 0 | 0 | 090000648250eadb | |||
| FDA-2015-N-2002-1980 | FDA | None FDA-2015-N-2002 | List of References for Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:10:16Z | 0 | 0 | 090000648250e0c7 | |||
| FDA-2015-N-2002-1985 | FDA | None FDA-2015-N-2002 | Reference 5 United States v. Bowen, 14-cr-00169-PAB, Rule 11(c)(1)(A) and (B) Plea Agreement and Statement of Facts Relevant to Sentencing (D. Colo. Jan. 29, 2015) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:18:51Z | 0 | 0 | 090000648250eadc | |||
| FDA-2015-N-2002-1982 | FDA | None FDA-2015-N-2002 | Reference 2 United States v. Carlson, 12-cr-00305-DSD-LIB, Amended Superseding Indictment (D. Minn. Sept. 11, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:12:21Z | 0 | 0 | 090000648250ead9 | |||
| FDA-2015-N-2002-1986 | FDA | None FDA-2015-N-2002 | Reference 6 United States v. Zeyid, 114-cr-0197, First Superseding Indictment (N.D. Ga. June 24, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:19:51Z | 0 | 0 | 090000648250ef2d | |||
| FDA-2015-N-2002-1977 | FDA | None FDA-2015-N-2002 | Petition to Stay and for Reconsideration | Other | Petition(s) | 2017-02-09T05:00:00Z | 2017 | 2 | 2017-02-09T05:00:00Z | 2017-02-09T15:45:28Z | 0 | 0 | 09000064824b6b0e | ||
| FDA-2015-N-2002-1978 | FDA | None FDA-2015-N-2002 | Acknowledgment Letter From FDA DDM to Sidley Austin LLP and Ropes & Gray LLP | Other | Acknowledgement Letter/Receipt | 2017-02-09T05:00:00Z | 2017 | 2 | 2017-02-09T05:00:00Z | 2017-02-09T16:48:37Z | 0 | 0 | 09000064824b6e4e | ||
| FDA-2015-N-2002-1976 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ``Intended Uses''; Delayed Effective Date | Rule | Delay of Effective Date | 2017-02-07T05:00:00Z | 2017 | 2 | 2017-02-07T05:00:00Z | 2017-02-07T14:31:31Z | 2017-02485 | 0 | 0 | 09000064824afc98 | |
| FDA-2015-N-2002-1975 | FDA | None FDA-2015-N-2002 | TAB C 2016-308 Jurisdiction RIA as Cleared by OMB.docx | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:57Z | 0 | 0 | 090000648245bac6 | |||
| FDA-2015-N-2002-1973 | FDA | None FDA-2015-N-2002 | TAB B 2016-308 Jurisdiction Final Rule Redline Changes | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:19:38Z | 0 | 0 | 090000648245bac4 | |||
| FDA-2015-N-2002-1974 | FDA | None FDA-2015-N-2002 | TAB C 2016-308 Jurisdiction Final Rule as Cleared by OMB | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:30Z | 0 | 0 | 090000648245bac5 | |||
| FDA-2015-N-2002-1972 | FDA | None FDA-2015-N-2002 | TAB A 2016-308 Jurisdiction Final Rule as Submitted to OMB | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:19:47Z | 0 | 0 | 090000648245bac3 | |||
| FDA-2015-N-2002-1971 | FDA | None FDA-2015-N-2002 | Memorandum to FDA DDM Tobacco Jurisdiction Final Rule | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:00Z | 0 | 0 | 090000648245bac2 | |||
| FDA-2015-N-2002-1945 | FDA | None FDA-2015-N-2002 | Reference 1 - Defendant's Memorandum of Points and Authorities in Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. U.S. re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:15Z | 0 | 0 | 0900006482453a8a | |||
| FDA-2015-N-2002-1958 | FDA | None FDA-2015-N-2002 | Reference 14 - NCI, President's Cancer Panel re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:18Z | 0 | 0 | 0900006482453ea0 | |||
| FDA-2015-N-2002-1950 | FDA | None FDA-2015-N-2002 | Reference 6 - Good-2016-Off-Label Drug Use and Adverse Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:33Z | 0 | 0 | 090000648245417e | |||
| FDA-2015-N-2002-1952 | FDA | None FDA-2015-N-2002 | Reference 8 - Avorn-2015-Forbidden and Permitted Statements re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:46Z | 0 | 0 | 0900006482454180 | |||
| FDA-2015-N-2002-1953 | FDA | None FDA-2015-N-2002 | Reference 9 - Kapczynski-2016-Free Speech and Pharmaceutical re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:54Z | 0 | 0 | 0900006482454181 | |||
| FDA-2015-N-2002-1947 | FDA | None FDA-2015-N-2002 | Reference 3 - Byron, Adolescents and Adults Perceptions of Natural Organic and re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:22Z | 0 | 0 | 090000648245417a | |||
| FDA-2015-N-2002-1944 | FDA | None FDA-2015-N-2002 | Jurisdiction References List re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-19T15:02:07Z | 0 | 0 | 0900006482453a89 | |||
| FDA-2015-N-2002-1959 | FDA | None FDA-2015-N-2002 | Reference 15 - IOM_Blueprint_2007 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:21Z | 0 | 0 | 0900006482453ea1 | |||
| FDA-2015-N-2002-1965 | FDA | None FDA-2015-N-2002 | Jurisdiction FRIA references_final2 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:44Z | 0 | 0 | 0900006482453ebd | |||
| FDA-2015-N-2002-1969 | FDA | None FDA-2015-N-2002 | Reference 4 - Size Standards Table re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:59Z | 0 | 0 | 0900006482453ec1 | |||
| FDA-2015-N-2002-1948 | FDA | None FDA-2015-N-2002 | Reference 4 - Green, Evidence of the Effects of Mandatory Disclaim re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:26Z | 0 | 0 | 090000648245417b | |||
| FDA-2015-N-2002-1951 | FDA | None FDA-2015-N-2002 | Reference 7 - Eguale-2016-Association of Off-Label Drug Use re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:36Z | 0 | 0 | 090000648245417f | |||
| FDA-2015-N-2002-1956 | FDA | None FDA-2015-N-2002 | Reference 12 - Kesselheim, ProspectsforRegulationofOffLabelDr re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:11Z | 0 | 0 | 0900006482453e9e | |||
| FDA-2015-N-2002-1970 | FDA | None FDA-2015-N-2002 | Reference 5 - U.S. Census - Tobacco and Tobacco Product re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:47:03Z | 0 | 0 | 0900006482453ec2 | |||
| FDA-2015-N-2002-1960 | FDA | None FDA-2015-N-2002 | Reference 16 - Roditis-2015-Adolescents' Perceptions of Risks re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:25Z | 0 | 0 | 0900006482453ea2 | |||
| FDA-2015-N-2002-1954 | FDA | None FDA-2015-N-2002 | Reference 10 - Cardarelli-2006-A cross-sectional evidence-bas re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:00Z | 0 | 0 | 0900006482454182 | |||
| FDA-2015-N-2002-1957 | FDA | None FDA-2015-N-2002 | Reference 13 - Stafford-2008-Regulating off-label drug use--r re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:14Z | 0 | 0 | 0900006482453e9f | |||
| FDA-2015-N-2002-1961 | FDA | None FDA-2015-N-2002 | Reference 17 - Vickerman-2013-Use of electronic cigarettes am re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:29Z | 0 | 0 | 0900006482453ea3 | |||
| FDA-2015-N-2002-1963 | FDA | None FDA-2015-N-2002 | Reference 19 - Jurisdiction Final Rule re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:35Z | 0 | 0 | 0900006482453ea5 | |||
| FDA-2015-N-2002-1966 | FDA | None FDA-2015-N-2002 | Reference 1 - Deeming Rule_FRIA re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:47Z | 0 | 0 | 0900006482453ebe | |||
| FDA-2015-N-2002-1946 | FDA | None FDA-2015-N-2002 | Reference 2 - Etter-2011-Electronic cigarette_ users profile re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:19Z | 0 | 0 | 0900006482454179 | |||
| FDA-2015-N-2002-1943 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Rule | Final Rule | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T05:00:00Z | 2017-01-09T15:27:31Z | 2016-31950 | 0 | 0 | 0900006482452b42 | |
| FDA-2015-N-2002-1955 | FDA | None FDA-2015-N-2002 | Reference 11 - Eisenberg, The Role of the FDA in Innovation P | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T22:50:08Z | 0 | 0 | 0900006482453e9d | |||
| FDA-2015-N-2002-1962 | FDA | None FDA-2015-N-2002 | Reference 18 - Gallup Consumption Habits re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:32Z | 0 | 0 | 0900006482453ea4 | |||
| FDA-2015-N-2002-1964 | FDA | None FDA-2015-N-2002 | Reference 20 - Janssen, Outline of the History of U.S. Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:39Z | 0 | 0 | 0900006482453ea6 | |||
| FDA-2015-N-2002-1967 | FDA | None FDA-2015-N-2002 | Reference 2, FDA, Safety and Effectiveness of Consumer Antiseptics Rub Products re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:51Z | 0 | 0 | 0900006482453ebf | |||
| FDA-2015-N-2002-1949 | FDA | None FDA-2015-N-2002 | Reference 5 - Kesselheim-2008-Pharmaceutical Promotion to Ph re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:29Z | 0 | 0 | 090000648245417d | |||
| FDA-2015-N-2002-1968 | FDA | None FDA-2015-N-2002 | Reference 3 - RTI, FDA Labeling Cost ModelFINAL re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:54Z | 0 | 0 | 0900006482453ec0 | |||
| FDA-2015-N-2002-0023 | FDA | None FDA-2015-N-2002 | Request for Extension from Campaign for Tobacco Free Kids et al. | Other | Request for Extension | 2016-01-15T05:00:00Z | 2016 | 1 | 2016-01-15T05:00:00Z | 2016-01-15T19:16:26Z | 0 | 0 | 0900006481d4062e | ||
| FDA-2015-N-2002-0008 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Reopening of the Comment Period | Proposed Rule | Reopening of Comment Period | 2015-11-30T05:00:00Z | 2015 | 11 | 2015-11-30T05:00:00Z | 2015-12-31T04:59:59Z | 2015-12-31T22:00:26Z | 2015-30271 | 0 | 0 | 0900006481d7964a |
| FDA-2015-N-2002-0002 | FDA | None FDA-2015-N-2002 | List of References re Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products Amendments to Regulations Regarding Intended Uses Proposed Rule | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:44:54Z | 0 | 0 | 0900006481c965b1 | |||
| FDA-2015-N-2002-0003 | FDA | None FDA-2015-N-2002 | Reference 1 - U.S. Dept of Commerce, Bureau of Economic Analysis Natiuonal Income and Product Accounts | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:45:11Z | 0 | 0 | 0900006481c965b2 | |||
| FDA-2015-N-2002-0005 | FDA | None FDA-2015-N-2002 | Reference 3 - Easley, David, and OHara - Ambiguity and Nonparticipation, The Role of Regulation- Review of Financial Studies | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:45:51Z | 0 | 0 | 0900006481c965b4 | |||
| FDA-2015-N-2002-0001 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ``Intended Uses'' | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-09-25T04:00:00Z | 2015-11-25T04:59:59Z | 2016-01-15T22:00:58Z | 2015-24313 | 0 | 0 | 0900006481c95e75 |
| FDA-2015-N-2002-0004 | FDA | None FDA-2015-N-2002 | Reference 2 - Ellsberg, Daniel -Risk, Ambiguity, and the Savage Axioms- The Quarterly Journal of Economics | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:45:34Z | 0 | 0 | 0900006481c965b3 | |||
| FDA-2015-N-2002-0006 | FDA | None FDA-2015-N-2002 | Reference 4 - Dimmock et al - Ambiguity Aversion and Household Portfolio Choice, Empirical Evidence- NBER Working Paper Series | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:46:10Z | 0 | 0 | 0900006481c9622e | |||
| FDA-2015-N-2002-0007 | FDA | None FDA-2015-N-2002 | Reference 5 - Defendant's Memorandum of Points and Authorities in Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. U.S. | Supporting & Related Material | Background Material | 2015-09-25T04:00:00Z | 2015 | 9 | 2015-12-03T12:46:32Z | 0 | 0 | 0900006481c9622f |
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