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9,522 rows where agency_id = "FDA" and posted_year = 2020 sorted by posted_date descending
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document_type 5
- Other 6,070
- Supporting & Related Material 2,602
- Notice 778
- Rule 37
- Proposed Rule 35
posted_year 1
- 2020 · 9,522 ✖
agency_id 1
- FDA · 9,522 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2020-E-2363-0001 | FDA | FDA-2020-E-2363 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:46:23Z | 0 | 0 | 09000064849d6369 | ||
| FDA-2020-E-2364-0002 | FDA | FDA-2020-E-2364 | Patent Term Extension Application for NURTEC ODT® Patent No 8,314,117 | Other | Application | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:56:21Z | 0 | 0 | 09000064849d636f | ||
| FDA-2020-E-2361-0002 | FDA | FDA-2020-E-2361 | Patent Term Extension Application for ENSPRYNG® Patent No 8,562,991 | Other | Application | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:33:58Z | 0 | 0 | 09000064849d615c | ||
| FDA-2020-E-2365-0002 | FDA | FDA-2020-E-2365 | Patent Term Extension Application for NURTEC ODT® Patent No 8,759,372 | Other | Application | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T15:04:43Z | 0 | 0 | 09000064849d63e4 | ||
| FDA-2020-E-2364-0001 | FDA | FDA-2020-E-2364 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:55:22Z | 0 | 0 | 09000064849d636e | ||
| FDA-2020-E-2363-0002 | FDA | FDA-2020-E-2363 | Patent Term Extension Application for ENSPRYNG® Patent No 10,662,245 | Other | Application | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:47:19Z | 0 | 0 | 09000064849d636a | ||
| FDA-2020-P-1769-0011 | FDA | FDA-2020-P-1769 | Response letter to Siri & Glimstad LLP from FDA CBER | Other | Response(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T18:19:46Z | 0 | 0 | 09000064849d6b35 | ||
| FDA-2016-N-0124-0410 | FDA | FDA-2016-N-0124 | Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability | Notice | Notice of Availability | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:14:51Z | 2020-28929 | 0 | 0 | 09000064849d654d | |
| FDA-2020-E-2365-0001 | FDA | FDA-2020-E-2365 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T15:03:44Z | 0 | 0 | 09000064849d63e3 | ||
| FDA-2020-E-2362-0001 | FDA | FDA-2020-E-2362 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:39:30Z | 0 | 0 | 09000064849d615f | ||
| FDA-2020-E-2362-0002 | FDA | FDA-2020-E-2362 | Patent Term Extension Application for ENSPRYNG® Patent No 10,022,319 | Other | Application | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:40:22Z | 0 | 0 | 09000064849d6366 | ||
| FDA-2020-E-2361-0001 | FDA | FDA-2020-E-2361 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T14:33:04Z | 0 | 0 | 09000064849d615b | ||
| FDA-2020-V-2292-0003 | FDA | FDA-2020-V-2292 | Variance Approval Letter from FDA CDRH to Irani Silva | Other | Approval for Variance (VRA) | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2020-12-31T16:11:07Z | 0 | 0 | 09000064849d63ea | ||
| FDA-2016-N-0124-0411 | FDA | FDA-2016-N-0124 | Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability | Other | Guidance | 2020-12-31T05:00:00Z | 2020 | 12 | 2020-12-31T05:00:00Z | 2024-11-12T23:26:51Z | 1 | 0 | 09000064849d6159 | ||
| FDA-2015-P-0703-0003 | FDA | FDA-2015-P-0703 | Citizen Petition Response to Sarah Salem-Robinson | Other | Response(s) | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T16:53:12Z | 0 | 0 | 09000064849d2636 | ||
| FDA-2020-V-2282-0003 | FDA | FDA-2020-V-2282 | Variance Approval Letter from FDA CDRH to MicaTronics LLC | Other | Approval for Variance (VRA) | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T16:33:49Z | 0 | 0 | 09000064849d20ba | ||
| FDA-2018-P-2073-0005 | FDA | FDA-2018-P-2073 | Citizen Petition Response to LMS Direct Research Foundation | Other | Response(s) | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T17:00:45Z | 0 | 0 | 09000064849d22af | ||
| FDA-2020-P-2360-0001 | FDA | FDA-2020-P-2360 | Citizen Petition from Pet Schooled The Educated Community | Other | Citizen Petition | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2024-11-12T23:26:46Z | 1 | 0 | 09000064849d0890 | ||
| FDA-2020-P-2357-0001 | FDA | FDA-2020-P-2357 | Citizen Petition from Keller and Heckman LLP on behalf of Nexira, Alland & Robert and Importers Service Corporation | Other | Citizen Petition | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2021-12-17T13:56:39Z | 0 | 0 | 09000064849ce2e5 | ||
| FDA-2020-P-2357-0002 | FDA | FDA-2020-P-2357 | Acknowledgment Letter from FDA DMS to Keller and Heckman LLP n behalf of Nexira, Alland & Robert, and Importers Service Corporation | Other | Acknowledgement Letter/Receipt | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T13:41:28Z | 0 | 0 | 09000064849ce2e6 | ||
| FDA-2020-P-2360-0002 | FDA | FDA-2020-P-2360 | Acknowledgment Letter from FDA DMS to Pet Schooled | Other | Acknowledgement Letter/Receipt | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2024-11-12T23:26:29Z | 1 | 0 | 09000064849d20b5 | ||
| FDA-2014-D-1804-0073 | FDA | FDA-2014-D-1804 | Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | Notice of Availability | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T13:31:56Z | 2020-28816 | 0 | 0 | 09000064849d16c7 | |
| FDA-2016-P-1398-0004 | FDA | FDA-2016-P-1398 | Citizen Petition Response to Dr. Hooman Noorchashm | Other | Response(s) | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T17:01:11Z | 0 | 0 | 09000064849d263b | ||
| FDA-2020-P-2357-0003 | FDA | FDA-2020-P-2357 | Appendix I Uebelhack re Citizen Petition from Keller and Heckman LLP on behalf of Nexira, Alland & Robert and Importers Service Corporation | Supporting & Related Material | Background Material | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T13:41:37Z | 0 | 0 | 09000064849ce2e9 | |||
| FDA-2018-N-3233-0002 | FDA | FDA-2018-N-3233 | Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee | Notice | Request for Nominations | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T13:28:30Z | 2020-28833 | 0 | 0 | 09000064849d18c9 | |
| FDA-2018-P-3843-0115 | FDA | FDA-2018-P-3843 | Citizen Petition Response to Hoomad Noorchashm | Other | Response(s) | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2020-12-30T17:06:07Z | 0 | 0 | 09000064849d22b1 | ||
| FDA-2014-D-1804-0074 | FDA | FDA-2014-D-1804 | Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff | Other | Guidance | 2020-12-30T05:00:00Z | 2020 | 12 | 2020-12-30T05:00:00Z | 2024-11-12T23:26:46Z | 1 | 0 | 09000064849d088d | ||
| FDA-2020-V-2356-0001 | FDA | FDA-2020-V-2356 | Variance Application from La Farm Animal Save | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T16:42:59Z | 0 | 0 | 09000064849cd180 | ||
| FDA-2020-N-2246-0001 | FDA | FDA-2020-N-2246 | Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 | Notice | Announcement | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:03:53Z | 2020-28714 | 0 | 0 | 09000064849cfd28 | |
| FDA-2020-V-2356-0002 | FDA | FDA-2020-V-2356 | Acknowledgment Letter from FDA DMS to La Farm Animal Save | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T16:46:33Z | 0 | 0 | 09000064849cd7a6 | ||
| FDA-2020-V-2350-0001 | FDA | FDA-2020-V-2350 | Variance Application from Jurijus Voronovas | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T14:41:00Z | 0 | 0 | 09000064849cb3a9 | ||
| FDA-2020-V-2346-0002 | FDA | FDA-2020-V-2346 | Acknowledgment Letter from FDA DMS to Jayden Romay Ruiz | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:15:26Z | 0 | 0 | 09000064849cbcad | ||
| FDA-2020-V-2347-0001 | FDA | FDA-2020-V-2347 | Variance Application from Silverhawk Aviation | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:11:33Z | 0 | 0 | 09000064849cbd6b | ||
| FDA-2020-V-2350-0002 | FDA | FDA-2020-V-2350 | Acknowledgment Letter from FDA DMS to Jurijus Voronovas | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T14:46:47Z | 0 | 0 | 09000064849cbccc | ||
| FDA-2010-N-0493-0013 | FDA | FDA-2010-N-0493 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:10:19Z | 2020-28608 | 0 | 0 | 09000064849cfdc6 | |
| FDA-2020-V-2345-0002 | FDA | FDA-2020-V-2345 | Acknowledgment Letter from FDA DMS to Shane Cassidy | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T15:06:38Z | 0 | 0 | 09000064849cb3a5 | ||
| FDA-2017-N-2021-0007 | FDA | FDA-2017-N-2021 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:10:55Z | 2020-28608 | 0 | 0 | 09000064849cfe9f | |
| FDA-2020-V-2347-0002 | FDA | FDA-2020-V-2347 | Acknowledgement Letter from FDA DMS to Silverhawk Aviation | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:11:47Z | 0 | 0 | 09000064849cbd71 | ||
| FDA-2017-N-1095-0009 | FDA | FDA-2017-N-1095 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:12:08Z | 2020-28608 | 0 | 0 | 09000064849cfe9d | |
| FDA-2020-V-2346-0001 | FDA | FDA-2020-V-2346 | Variance Application from Jayden Romay Ruiz | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:15:10Z | 0 | 0 | 09000064849cb9a4 | ||
| FDA-2020-P-1633-0005 | FDA | FDA-2020-P-1633 | Interim Response Letter from FDA CBER to Foley Hoag, LLP (on behalf of the Microbiome Therapeutics Innovation Group) | Other | Letter(s) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T20:33:10Z | 0 | 0 | 09000064849d0105 | ||
| FDA-2020-D-1825-0015 | FDA | FDA-2020-D-1825 | Investigational COVID-19 Convalescent Plasma Guidance for Industry | Other | Guidance | 2020-12-29T05:00:00Z | 2020 | 12 | 2021-01-04T05:00:00Z | 2024-11-06T23:44:24Z | 1 | 0 | 09000064849dc6c4 | ||
| FDA-2020-V-2344-0002 | FDA | FDA-2020-V-2344 | Acknowledgment Letter from FDA DMS to Joshua Coonradt | Other | Acknowledgement Letter/Receipt | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:17:52Z | 0 | 0 | 09000064849cb386 | ||
| FDA-2012-N-0197-0010 | FDA | FDA-2012-N-0197 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:12:34Z | 2020-28608 | 0 | 0 | 09000064849cfe9c | |
| FDA-2011-N-0424-0011 | FDA | FDA-2011-N-0424 | Agency Information Collection Activities; Proposals, Submissions, and Approvals | Notice | Notice of Approval | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T17:11:23Z | 2020-28608 | 0 | 0 | 09000064849cfe9e | |
| FDA-2020-V-2345-0001 | FDA | FDA-2020-V-2345 | Variance Application from Shane Cassidy | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T15:02:00Z | 0 | 0 | 09000064849cb27f | ||
| FDA-2020-V-2344-0001 | FDA | FDA-2020-V-2344 | Variance Application from Joshua Coonradt | Other | Application for Variance (VAR) | 2020-12-29T05:00:00Z | 2020 | 12 | 2020-12-29T05:00:00Z | 2020-12-29T18:17:30Z | 0 | 0 | 09000064849cb2cb | ||
| FDA-2020-N-2252-0001 | FDA | FDA-2020-N-2252 | Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments | Notice | Request for Comments | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2021-03-30T03:59:59Z | 2021-03-30T01:00:27Z | 2020-28602 | 0 | 0 | 09000064849cc7ab |
| FDA-2020-V-2321-0002 | FDA | FDA-2020-V-2321 | Acknowledgment Letter from FDA DMS to Zachary Taylor | Other | Acknowledgement Letter/Receipt | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T14:40:16Z | 0 | 0 | 09000064849bb5e2 | ||
| FDA-2020-V-2348-0002 | FDA | FDA-2020-V-2348 | Acknowledgment Letter from FDA DMS to Below the Waves LLC | Other | Acknowledgement Letter/Receipt | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:41:48Z | 0 | 0 | 09000064849cb2cd | ||
| FDA-2020-V-2348-0001 | FDA | FDA-2020-V-2348 | Variance Application from Below the Waves LLC | Other | Application for Variance (VAR) | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:40:51Z | 0 | 0 | 09000064849cb2c9 | ||
| FDA-2020-D-0530-0668 | FDA | FDA-2020-D-0530 | Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Comment Period | Notice | Notice of Availability | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2021-02-26T04:59:59Z | 2021-02-27T02:00:26Z | 2020-28559 | 0 | 0 | 09000064849cc892 |
| FDA-2017-D-4303-0003 | FDA | FDA-2017-D-4303 | Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry; Availability | Notice | Notice of Availability | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T16:56:08Z | 2020-28560 | 0 | 0 | 09000064849cc7af | |
| FDA-2020-V-2352-0001 | FDA | FDA-2020-V-2352 | Variance Application from Gregory Class | Other | Application for Variance (VAR) | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T20:18:43Z | 0 | 0 | 09000064849cbe4d | ||
| FDA-2020-N-1440-0001 | FDA | FDA-2020-N-1440 | Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | Notice | Request for Comments | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2021-02-09T04:59:59Z | 2021-02-10T02:00:46Z | 2020-28558 | 0 | 0 | 09000064849cc88e |
| FDA-2020-V-2349-0001 | FDA | FDA-2020-V-2349 | Variance Application from John Nelson | Other | Application for Variance (VAR) | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:42:29Z | 0 | 0 | 09000064849cb380 | ||
| FDA-2020-V-2351-0002 | FDA | FDA-2020-V-2351 | Acknowledgment Letter from FDA DMS to One Source Media Solutions | Other | Acknowledgement Letter/Receipt | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:49:56Z | 0 | 0 | 09000064849cbd6f | ||
| FDA-2020-V-2321-0001 | FDA | FDA-2020-V-2321 | Variance Application from Zachary Taylor | Other | Application for Variance (VAR) | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T14:39:34Z | 0 | 0 | 09000064849bb5df | ||
| FDA-2020-N-0008-0022 | FDA | FDA-2020-N-0008 | Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee; Renewal | Notice | Renewals | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T16:53:17Z | 2020-28561 | 0 | 0 | 09000064849cc890 | |
| FDA-2020-V-2352-0002 | FDA | FDA-2020-V-2352 | Acknowledgment Letter from FDA DMS to Gregory Class | Other | Acknowledgement Letter/Receipt | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T20:20:57Z | 0 | 0 | 09000064849ccac9 | ||
| FDA-2020-V-2351-0001 | FDA | FDA-2020-V-2351 | Variance Application from One Source Media Solutions | Other | Application for Variance (VAR) | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:49:04Z | 0 | 0 | 09000064849cbd6d | ||
| FDA-2020-V-2349-0002 | FDA | FDA-2020-V-2349 | Acknowledgment Letter from FDA DMS to John Nelson | Other | Acknowledgement Letter/Receipt | 2020-12-28T05:00:00Z | 2020 | 12 | 2020-12-28T05:00:00Z | 2020-12-28T21:48:27Z | 0 | 0 | 09000064849cb383 | ||
| FDA-2020-E-2337-0001 | FDA | FDA-2020-E-2337 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:31:44Z | 0 | 0 | 09000064849c11a1 | ||
| FDA-2020-E-2337-0002 | FDA | FDA-2020-E-2337 | Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:32:55Z | 0 | 0 | 09000064849c11a2 | ||
| FDA-2020-V-2320-0002 | FDA | FDA-2020-V-2320 | Acknowledgment Letter from FDA DMS to Neil Hotkiewicz | Other | Acknowledgement Letter/Receipt | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T12:49:14Z | 0 | 0 | 09000064849bb5dc | ||
| FDA-2020-P-2008-0006 | FDA | FDA-2020-P-2008 | Interim Response Letter from FDA CDRH to Philips Respironics | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T14:06:37Z | 0 | 0 | 09000064849c1209 | ||
| FDA-2020-V-2342-0002 | FDA | FDA-2020-V-2342 | Acknowledgment Letter from FDA DMS to Chris Cook | Other | Acknowledgement Letter/Receipt | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T20:25:34Z | 0 | 0 | 09000064849c2508 | ||
| FDA-2020-V-2341-0001 | FDA | FDA-2020-V-2341 | Variance Application from FiveAM Theater | Other | Application for Variance (VAR) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T19:21:30Z | 0 | 0 | 09000064849c2113 | ||
| FDA-2020-V-2188-0003 | FDA | FDA-2020-V-2188 | Variance Approval Letter from FDA CDRH to SONY Corporation | Other | Approval for Variance (VRA) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T14:57:35Z | 0 | 0 | 09000064849c120d | ||
| FDA-2020-E-2334-0002 | FDA | FDA-2020-E-2334 | Patent Term Extension Application for ROZLYTREK® Patent No 8,673,893 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:10:17Z | 0 | 0 | 09000064849c0c38 | ||
| FDA-2020-E-2338-0001 | FDA | FDA-2020-E-2338 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:38:21Z | 0 | 0 | 09000064849c11a5 | ||
| FDA-2020-N-2272-0001 | FDA | FDA-2020-N-2272 | Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications | Notice | Withdrawal | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T15:00:57Z | 2020-28346 | 0 | 0 | 09000064849c0835 | |
| FDA-2020-V-2342-0001 | FDA | FDA-2020-V-2342 | Variance Application from Chris Cook | Other | Application for Variance (VAR) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T20:24:51Z | 0 | 0 | 09000064849c211b | ||
| FDA-2020-E-2334-0001 | FDA | FDA-2020-E-2334 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:09:00Z | 0 | 0 | 09000064849c0c37 | ||
| FDA-2020-V-2320-0001 | FDA | FDA-2020-V-2320 | Variance Application from Neil Hotkiewicz | Other | Application for Variance (VAR) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T12:46:17Z | 0 | 0 | 09000064849b9020 | ||
| FDA-2020-E-2333-0001 | FDA | FDA-2020-E-2333 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:01:31Z | 0 | 0 | 09000064849c0a4b | ||
| FDA-2010-N-0155-0253 | FDA | FDA-2010-N-0155 | Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive | Notice | 60 Day Proposed Information Collection | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2021-02-23T04:59:59Z | 2020-12-23T15:07:58Z | 2020-28353 | 0 | 0 | 09000064849c0f93 |
| FDA-2020-N-2267-0001 | FDA | FDA-2020-N-2267 | Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets | Notice | Withdrawal | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T15:11:29Z | 2020-28283 | 0 | 0 | 09000064849c0fe7 | |
| FDA-2020-V-2343-0002 | FDA | FDA-2020-V-2343 | Acknowledgment Letter from FDA DMS to Ben Black | Other | Acknowledgement Letter/Receipt | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T19:24:59Z | 0 | 0 | 09000064849c142f | ||
| FDA-2020-D-1136-0044 | FDA | FDA-2020-D-1136 | Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry | Other | Guidance | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2023-05-12T03:59:59Z | 2023-05-08T19:02:22Z | 0 | 0 | 09000064849bcedf | |
| FDA-2020-E-2335-0001 | FDA | FDA-2020-E-2335 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:15:28Z | 0 | 0 | 09000064849c1160 | ||
| FDA-2020-E-2336-0001 | FDA | FDA-2020-E-2336 | Letter from U S Patent and Trademark Office | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:22:21Z | 0 | 0 | 09000064849c1164 | ||
| FDA-2020-P-2010-0007 | FDA | FDA-2020-P-2010 | Interim Response Letter from FDA CDRH to Philips Respironics | Other | Letter(s) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T14:01:45Z | 0 | 0 | 09000064849c1206 | ||
| FDA-2020-P-2322-0002 | FDA | FDA-2020-P-2322 | Acknowledgment Letter from FDA DMS to Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America | Other | Acknowledgement Letter/Receipt | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:43:35Z | 0 | 0 | 09000064849bae17 | ||
| FDA-2020-E-2336-0002 | FDA | FDA-2020-E-2336 | Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:25:27Z | 0 | 0 | 09000064849c1165 | ||
| FDA-2020-E-2338-0002 | FDA | FDA-2020-E-2338 | Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:39:55Z | 0 | 0 | 09000064849c11a6 | ||
| FDA-2020-V-2205-0004 | FDA | FDA-2020-V-2205 | Variance Approval Letter from FDA CDRH to MultiMedia Consulting Services, Inc | Other | Approval for Variance (VRA) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T21:09:03Z | 0 | 0 | 09000064849c5891 | ||
| FDA-2020-E-2333-0002 | FDA | FDA-2020-E-2333 | Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:02:47Z | 0 | 0 | 09000064849c0a4c | ||
| FDA-2020-E-2335-0002 | FDA | FDA-2020-E-2335 | Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356 | Other | Application | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T13:16:33Z | 0 | 0 | 09000064849c1161 | ||
| FDA-2017-D-4303-0002 | FDA | FDA-2017-D-4303 | Guidance for Industry REMS.eSub | Other | Guidance | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2024-11-12T23:27:37Z | 1 | 0 | 09000064849c3775 | ||
| FDA-2014-N-0386-0005 | FDA | FDA-2014-N-0386 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs | Notice | 30 Day Proposed Information Collection | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2021-01-23T04:59:59Z | 2021-01-23T02:02:30Z | 2020-28349 | 0 | 0 | 09000064849c0f39 |
| FDA-2020-V-2343-0001 | FDA | FDA-2020-V-2343 | Variance Application from Ben Black | Other | Application for Variance (VAR) | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T19:23:13Z | 0 | 0 | 09000064849c142c | ||
| FDA-2020-V-2341-0002 | FDA | FDA-2020-V-2341 | Acknowledgment Letter from FDA DMS to FiveAM Theater | Other | Acknowledgement Letter/Receipt | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2020-12-23T19:22:09Z | 0 | 0 | 09000064849c2114 | ||
| FDA-2020-P-2322-0001 | FDA | FDA-2020-P-2322 | Citizen Petition from Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America | Other | Citizen Petition | 2020-12-23T05:00:00Z | 2020 | 12 | 2020-12-23T05:00:00Z | 2024-11-12T23:26:39Z | 1 | 0 | 09000064849bae16 | ||
| FDA-2020-P-2317-0001 | FDA | FDA-2020-P-2317 | Citizen Petition from Baxter Healthcare Corporation | Other | Citizen Petition | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2024-11-12T23:27:19Z | 1 | 0 | 09000064849b07a7 | ||
| FDA-2020-V-2198-0003 | FDA | FDA-2020-V-2198 | Variance Approval Letter from CDRH to Old Dominion University | Other | Approval for Variance (VRA) | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2020-12-22T14:48:03Z | 0 | 0 | 09000064849b7b8d | ||
| FDA-2020-E-2325-0002 | FDA | FDA-2020-E-2325 | Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057 | Other | Application | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2020-12-22T21:17:46Z | 0 | 0 | 09000064849bd25b | ||
| FDA-2020-P-2318-0001 | FDA | FDA-2020-P-2318 | Suitability Citizen Petition from Lachman Consulting Services, Inc. | Other | Petition(s) | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2024-11-12T23:26:39Z | 1 | 0 | 09000064849b0718 | ||
| FDA-2020-P-2318-0002 | FDA | FDA-2020-P-2318 | Acknowledgement Letter from FDA DMS to Lachman Consulting Services, Inc. | Other | Acknowledgement Letter/Receipt | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2020-12-22T15:18:53Z | 0 | 0 | 09000064849b1603 | ||
| FDA-2020-P-2317-0002 | FDA | FDA-2020-P-2317 | Acknowledgment Letter from FDA DMS to Baxter Healthcare Corporation | Other | Acknowledgement Letter/Receipt | 2020-12-22T05:00:00Z | 2020 | 12 | 2020-12-22T05:00:00Z | 2020-12-22T20:00:11Z | 0 | 0 | 09000064849b07aa |
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