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

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9,522 rows where agency_id = "FDA" and posted_year = 2020 sorted by posted_date descending

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  • 2020 · 9,522 ✖

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  • 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
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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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