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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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