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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

39 rows where agency_id = "FDA" and docket_id = "FDA-1995-D-0288" sorted by posted_date descending

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  • FDA · 39 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1995-D-0288-0051 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:19Z   0 0 0900006484bd4b2d
FDA-1995-D-0288-0053 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 9 - Comparability Protocols for Human Drugs and Biologics April 2016 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:31Z   0 0 0900006484bd4b2f
FDA-1995-D-0288-0054 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:37Z   0 0 0900006484bd4b30
FDA-1995-D-0288-0052 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 7 - ICH Q 12 Annex RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:25Z   0 0 0900006484bd4b2e
FDA-1995-D-0288-0055 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 23 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research March 2019 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:44Z   0 0 0900006484bd4b31
FDA-1995-D-0288-0050 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 PAC FINAL GUIDANCE reference list RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:11Z   0 0 0900006484bcd0c7
FDA-1995-D-0288-0049 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Other Guidance 2021-06-24T04:00:00Z 2021 6 2021-06-24T04:00:00Z   2024-11-12T23:32:40Z   1 0 0900006484baa9ff
FDA-1995-D-0288-0048 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability Notice Notice of Availability 2021-06-24T04:00:00Z 2021 6 2021-06-24T04:00:00Z   2021-06-24T14:02:39Z 2021-13392 0 0 0900006484ba948e
FDA-1995-D-0288-0030 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2018-01-04T05:00:00Z 2018 1     2018-01-04T14:41:50Z   0 0 0900006482d96265
FDA-1995-D-0288-0031 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2018-01-04T05:00:00Z 2018 1     2018-01-04T14:41:58Z   0 0 0900006482d962c0
FDA-1995-D-0288-0011 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 08 Reference 7- Guidance for Industry Q10 Pharmaceutical Quality System re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:27Z   0 0 0900006482d5898a
FDA-1995-D-0288-0016 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 13 Reference 12 - Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for Allergenic Extract re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:13Z   0 0 0900006482d5898f
FDA-1995-D-0288-0006 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 03 Reference 2 - Supplements and Other Changes to an Approved Application Final Rule re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:39:49Z   0 0 0900006482d5894a
FDA-1995-D-0288-0022 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 19 Reference 18 - Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:57Z   0 0 0900006482d58999
FDA-1995-D-0288-0023 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 20 Reference 19 - Q5D Quality of Biotechnological Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological Biological Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:07Z   0 0 0900006482d5899a
FDA-1995-D-0288-0026 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 23 Reference 22 - Guidance Document Post-Notice of Compliance (NOC) Changes Quality Document - Canada_ca re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:29Z   0 0 0900006482d5899d
FDA-1995-D-0288-0009 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 06 Reference 5- Guidance for Industry Changes to An Approved Application for Specified Biotechnology and Specified Synthetic Biological Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:12Z   0 0 0900006482d58988
FDA-1995-D-0288-0017 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 14 Reference 13 - Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:22Z   0 0 0900006482d58990
FDA-1995-D-0288-0018 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 15 Reference 14 - Draft Guidance for Industry Comparability Protocols for Human Drugs and Biologics Chemsitry Manufacturing and Controls Information re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:29Z   0 0 0900006482d58995
FDA-1995-D-0288-0025 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 22 Reference 21 - Guidance for Industry Qualtiy Systems Approach to Pharamceutical CGMP Regulations re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:22Z   0 0 0900006482d5899c
FDA-1995-D-0288-0020 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 17 Reference 16 - Guidance for Industry Q6B Specifications Tests Procedures and Acceptance Criteria for Biotechnological Biological Prodcuts re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:44Z   0 0 0900006482d58997
FDA-1995-D-0288-0013 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 10 Reference 9 - Guidance for Industry For the Submission of Chemistry Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products Animal re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:47Z   0 0 0900006482d5898c
FDA-1995-D-0288-0012 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 09 Reference 8 - Guidance for Industry Q11 Development and Manufacture of Drug Substances re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:39Z   0 0 0900006482d5898b
FDA-1995-D-0288-0019 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 16 Reference 15 - Draft Guidance for Industry Established Conditions Reportable CMC Changes for Approved Drug and Biologic Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:36Z   0 0 0900006482d58996
FDA-1995-D-0288-0024 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 21 Reference 20 -Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingrediants re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:15Z   0 0 0900006482d5899b
FDA-1995-D-0288-0004 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 01 List of References re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:39:35Z   0 0 0900006482d58948
FDA-1995-D-0288-0002 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry; Availability Notice Notice of Availability 2017-12-22T05:00:00Z 2017 12 2017-12-22T05:00:00Z 2018-03-23T03:59:59Z 2018-03-23T13:00:58Z 2017-27589 0 0 0900006482d56bc8
FDA-1995-D-0288-0021 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 18 Reference 17 - Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:50Z   0 0 0900006482d58998
FDA-1995-D-0288-0007 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 04 Reference 3 - Quidance for Industry Q9 Quality Risk Management re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:39:57Z   0 0 0900006482d5894b
FDA-1995-D-0288-0014 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 11 Reference 10 - Guidance for Industry Content and Format of Chemistry Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:56Z   0 0 0900006482d5898d
FDA-1995-D-0288-0015 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 12 Reference 11 - Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:41:05Z   0 0 0900006482d5898e
FDA-1995-D-0288-0028 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:44Z   0 0 0900006482d58788
FDA-1995-D-0288-0008 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 05 Reference 4 - Guidance for Industry Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Furthe Manufacture re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:05Z   0 0 0900006482d5894c
FDA-1995-D-0288-0003 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Other Guidance 2017-12-22T05:00:00Z 2017 12 2017-12-22T05:00:00Z 2018-03-23T03:59:59Z 2024-11-07T01:16:03Z   1 0 0900006482d58944
FDA-1995-D-0288-0027 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality M4Q(R1) re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:35Z   0 0 0900006482d58787
FDA-1995-D-0288-0005 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 02 Reference 1 - Changes to an Approved Application Final Rule re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:39:41Z   0 0 0900006482d58949
FDA-1995-D-0288-0010 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 07 Reference 6 Guidance for Industry Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:40:20Z   0 0 0900006482d58989
FDA-1995-D-0288-0029 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 24 Reference 23 Quidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry Supporting & Related Material Background Material 2017-12-22T05:00:00Z 2017 12     2017-12-22T16:42:53Z   0 0 0900006482d5899e
FDA-1995-D-0288-0001 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Guidance: Changes to be Reported for Product and Establishment License Application Notice Guidance 2017-07-28T04:00:00Z 2017 7 2017-07-28T04:00:00Z   2017-07-28T20:17:33Z   0 0 0900006480598d46

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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