documents

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

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27 rows where docket_id = "FDA-2006-N-0515" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2006-N-0515-0091 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 4 Evaluation of How Best to Communicate with Healthcare Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women A Mental Models Research Report Final Report re Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467) Supporting & Related Material Background Material 2014-12-30T05:00:00Z 2014 12     2014-12-30T18:22:18Z   0 0 090000648199a463
FDA-2006-N-0515-0074 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 5 - Adam, M. P., J. E. Polifka, and J. M. Friedman, "Evolving Knowledge of the Teratogenicity of Medications in Human Pregnancy." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:28Z   0 0 090000648195b8ba
FDA-2006-N-0515-0080 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 11 - U.S. Food and Drug Administration, "Reviewer Guidance, Evaluating the Risks of Drug Exposure in Human Pregnancies," 2005. re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:09Z   0 0 090000648195b8e1
FDA-2006-N-0515-0083 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 14 - Tracy, T. S., et al. "Temporal Changes in Drug Metabolism (CYP1A2, CYP2D6 and CYP3A Activity) During Pregnancy." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:29Z   0 0 090000648195b8e5
FDA-2006-N-0515-0075 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 6 - Law, R., P. Bozzo, G. Koren, et al. "FDA Pregnancy Risk Categories and the CPS. Do They Help or Are They a Hindrance?" re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:36Z   0 0 090000648195b8dc
FDA-2006-N-0515-0071 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 2 - Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467) re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:10Z   0 0 090000648195b8b7
FDA-2006-N-0515-0072 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 3 - U.S. Food and Drug Administration, "Guidance for Industry, Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format," re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:15Z   0 0 090000648195b8b8
FDA-2006-N-0515-0078 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 9 - Rynn, L., J. Cragan, and A. Correa, "Update on Overall Prevalence of Major Birth Defects--Atlanta, Georgia, 1978-2005." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:56Z   0 0 090000648195b8df
FDA-2006-N-0515-0084 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 15 - Anderson, G. D., "Pregnancy-Induced Changes in Pharmacokinetics." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:36Z   0 0 090000648195b8e6
FDA-2006-N-0515-0082 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 13 - FDA, "Guidance for industry, M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals and the International Conference on Harmonisation S5 (R2) Guideline: Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility,". re Content and Format of Labeling for Human Prescription Drug Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:22Z   0 0 090000648195b8e3
FDA-2006-N-0515-0087 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 18 U.S. Food and Drug Administration, "Draft Guidance for industry Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling," re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:53Z   0 0 090000648195b8e9
FDA-2006-N-0515-0086 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 17 - Sachs, H. C. and Committee on Drugs. "The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:47Z   0 0 090000648195b8e8
FDA-2006-N-0515-0076 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 7 - U.S. Food and Drug Administration "Guidance for industry, Establishing Pregnancy Exposure Registries," re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:42Z   0 0 090000648195b8dd
FDA-2006-N-0515-0070 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 1 - Decision Partners, LLC, "Evaluation of How Best to Communicate to Healthcare Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women: A Mental Models Research Report," re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:03Z   0 0 090000648195b8b5
FDA-2006-N-0515-0069 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 References List re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:43:25Z   0 0 090000648195b8b4
FDA-2006-N-0515-0079 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 10 - American College of Obstetricians and Gynecologists Frequently Asked Questions: Miscarriage and Molar Pregnancy, 2011 re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:02Z   0 0 090000648195b8e0
FDA-2006-N-0515-0073 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 4 - Kweder, S. L., "Drugs and Biologics in Pregnancy and Breastfeeding: FDA in the 21st Century." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:22Z   0 0 090000648195b8b9
FDA-2006-N-0515-0077 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 8 - U.S. Food and Drug Administration "Guidance for Industry, Reproductive and Developmental Toxicities--Integrating Study Results to Assess Concerns," re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:48:49Z   0 0 090000648195b8de
FDA-2006-N-0515-0081 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 12 - U.S. Food and Drug Administration, "Guidance for industry, Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications," 2006. re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:15Z   0 0 090000648195b8e2
FDA-2006-N-0515-0085 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 16 - American Academy of Pediatrics Policy Statement. "Breastfeeding and the Use of Human Milk." re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Supporting & Related Material Background Material 2014-12-05T05:00:00Z 2014 12     2014-12-05T14:49:41Z   0 0 090000648195b8e7
FDA-2006-N-0515-0090 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 3 Final Report Evaluation of How Best to Communicate to Healthcare Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women re Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467) Supporting & Related Material Background Material 2014-12-04T05:00:00Z 2014 12     2014-12-30T18:20:07Z   0 0 090000648199a462
FDA-2006-N-0515-0068 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Rule Final Rule 2014-12-04T05:00:00Z 2014 12 2014-12-04T05:00:00Z   2014-12-04T15:08:11Z 2014-28241 0 0 090000648195a53f
FDA-2006-N-0515-0088 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 1 U.S. Bureau of Labor Statistics Occupational Employment Statistics May 2011 National Industry-Specific Occupational Employment and Wage Estimates NAICS 325400 - Pharmaceutical and Medicine Manufacturingre Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467) Supporting & Related Material Background Material 2014-12-04T05:00:00Z 2014 12     2014-12-30T18:19:43Z   0 0 090000648199a460
FDA-2006-N-0515-0089 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Reference 2 O'Reilly, Pharma scales back drug samples to physician offices re Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467) Supporting & Related Material Background Material 2014-12-04T05:00:00Z 2014 12     2014-12-30T18:19:54Z   0 0 090000648199a461
FDA-2006-N-0515-0027 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Regulations Policy and Management Staff [OMB Changes- May 29, 2008] - Reference Other REF-Reference Material (external attachments) 2008-08-10T04:00:00Z 2008 8 2008-08-10T04:00:00Z   2025-06-13T02:10:56Z   0 0 090000648061c8a0
FDA-2006-N-0515-0001 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling Notice NPR-Notice of Proposed Rule-Making 2008-05-29T04:00:00Z 2008 5 2008-05-29T04:00:00Z 2008-08-28T03:59:59Z 2025-06-13T01:58:23Z E8-11806 0 0 09000064806051dd
FDA-2006-N-0515-0002 FDA Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling FDA-2006-N-0515 Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, References Supporting & Related Material BKG-Background Material 2008-05-29T04:00:00Z 2008 5     2025-06-13T19:54:17Z   0 0 090000648060328b

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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);