documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
39 rows where docket_id = "FDA-1995-D-0288" sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
document_type 3
agency_id 1
- 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 |
Advanced export
JSON shape: default, array, newline-delimited, object
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);