Source: http://www.chpa-info.org/scienceregulatory/CHPA_Submissions.aspx
Timestamp: 2013-05-22 10:36:31
Document Index: 517878921

Matched Legal Cases: ['art 1', 'art 2', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Home > Science & Regulatory > CHPA Submissions
To FDA and Other Government Agencies and Institutions (1995-present) Docket Number
Ingredient/Topic
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Notification Procedures for Statements on Dietary Supplements
FDA-2011-N-0900
Unique Device Identification System; FDA, Proposed Rule
77 Fed. Reg. 59702
U.S.-EU Regulatory Compatibility, Request for Comments from the Public
FDA–2012–N–0781
Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on the Pediatric Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on Pediatric Advisory Committee
FDA-2012-D-0529
Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use - Labeling for Products That Contain Acetaminophen
Docket No. FDA-2012-N-0171
Using Innovative Technologies and other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription (these comments supplement the association’s March 22, 2012, presentation at FDA’s public meeting on the subject)
FDA-2011-N-0842
Gluten in Drug Products: Request for Information and Comments
78N-0301
External Analgesic Drug Products for OTC Human Use
CMS-5060-P
Proposed Rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests
FDA-2011-D-0620-0001
Guidance for Industry; Self-Selection for Nonprescription Drug Products
RIN 3209-AA04
FDA-1978-N-0018 (formerly Docket No. 1978N-0038)
Advance Notice of Proposed Rulemaking: Sunscreen Drug Products for OTC Human Use; Request for Data and Information Regarding Dosage Forms
FDA-1978-N-0018 (formerly 1978N-0038)
Proposed Rule: Revised Effectiveness Determination; Sunscreen Drug Products for OTC Human Use
Hazard Identification Materials for Fluoride and Its Salts
FDA-2010-D-0509
Draft Guidance for Industry on Enforcement Policy for OTC Sunscreen Products Marketed Without an Approved Application
FDA 2011-N-0449
SPF Labeling and Testing Requirements and Drug Facts Labeling for OTC Sunscreen Drug Products
FDA-2010-D-0530
Drug Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
FDA-2011-N-0002
Analgesic and Antipyretic Claims for Labeling for Children 6 Months to 2 Years
FDA–2010–N–0002
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatrics Advisory Committee to Discuss Use of Over-the-Counter Acetaminophen in Children
FDA Food Advisory Committee Public Meeting March 30-31, 2011: Whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior
FDA-2000-P-0102, FDA-2000-P-0133, and FDA-2006-P-0033
Food Labeling; Health Claims; Phytosterols and Risk of Coronary Heart Disease (Proposed Rule)
FDA-2010-D-0503
Draft Guidance for Industry on Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application
Alternative Safety Information Database Rule Proposal from Commissioners Anne Northup and Nancy Nord
FDA-2010-N-0001
Drug Safety and Risk Management Advisory Committee meeting to discuss the abuse potential of dextromethorphan and the public health benefits and risks of this ingredient as a cough suppressant (appendices 1, 2, and 3)
CHPA and CRN Amici Brief with the U.S. Supreme Court in AER Reporting Standard Case
FDA-2009-N-0247
FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration
Consumer Product Safety Information Database
External Analgesic Drug Producs for OTC Human Use
FDA-2009-D-0322
Dosage Delivery Devices for OTC Liquid Drug Products Guidance
FDA-2009-N-0664
Nomination for a Nonvoting Member Representing Industry Interests on the CFSAN Food Advisory Committee
FDA-2008-N-0334; RIN 0910-AF96
FDA -2009-N-0247
FDA Transparency Task Force; Public Meeting; Request for Comments
FDA-1977-N-0013
Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Clarification of Provisions in the Final Rule
Organ-Specific Warnings; Internal Analgesics, Antipyretic, and Antirheumatic Drug Products for OTC Human Use—Request for Agency Exercise of Enforcement Discretion on a Phrase
FDA-2009-D-0181
Guidance for Industry; Label Comprehension Studies for Nonprescription Drug Products
FDA-2009-N-0138-0001
Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee (June 29 and 30, 2009)
Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108
Proposition 65 Beneficial Nutrients Regulatory Concept
FDA-2008-N-0466
OTC Cough and Cold Medications for Pediatric Use; Notice of Public Hearing
FDA-2008-N-0389
Food and Drug Administration Amendments Act of 2007 Prohibition Against Food to Which Drugs or Biological Products Have Been Added
FDA-2005-N-0464
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
CHPA Comments on Consumer Product Safety Commission Section 102 Certificate Requirements
Industry Coalition Comments on Consumer Product Safety Commission Section 102 Certificate Requirements
CHPA Response to Request for Relevant Information on the Developmental and Reproductive Toxicity of Caffeine
FDA-2008-N-0416
CHPA Position Statement on Engineered Nanomaterials (Nanotechnology)
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; . . . Dextromethorphan
FDA-2008-D-0413
FDA Draft Guidance for Industry, Residual Solvents in Drug Products Marketed in the United States, August 2008
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
1981N-0033P
Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/ Antiplaque Drug Products; Establishment of a Monograph; Proposed Rules
Response to Request for Public Participation, Notice of Public Workshop, Proposition 65 Regulatory Update Project—Labor Code Mechanism Regulatory Concepts; Attachment A
FDA-2008-N-2081
Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting; Request for Comments
Proposition 65 Regulatory Update Project, Beneficial Nutrients Regulatory Concept
FDA-2008-N-0040
Advanced Notice of Proposed Rulemaking for Food Labeling: Revision of Reference Values and Mandatory Nutrients
2007D-0496 and 2007D-0491
Draft Guidance for Industry on Questions and Answers Re: the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act and Questions and Answers Re: the Labeling of Dietary Supplements as Required by the Dietary Supplemlent and Nonprescription Drug Consumer Protection Act (attachment)
1978N-0038
Sunscreen Products for OTC Human Use; Proposed Amendment of Final Monograph
2007N-0356
Behind the Counter Availability of Certain Drugs; Public Meeting
Request for Extension of Comment Period: Advanced Notice of Proposed Rulemaking for Food Labeling: Revision of Reference Values and Mandatory Nutrients
2007D-0388 and 2007D-0386
Notice of Draft Guidance for Industry: Questions and Answers Re: Adverse Event Reporting and Recordkeeping for Dietary Supplements and Notice of Drug Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Notice on Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (request for extension)
2007N-0186; RIN 0910-AB88
Interim Final Rule on Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (request for extension)
Request for Nominations for Nonvoting Industry Representatives on the Food Safety Public Advisory Committee
CV for Dr. George BurdockCV for Dr. Richard Cotter
CHPA's Nomination for Industry Representative to the Nonprescription Drugs Advisory Committee
CV for Dr. Edward Nelson
Request for Notification from Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Food Safety Public Advisory Committee
1977N-0094L, RIN 0901-AF36
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling
1998 N-0337C; RIN No. 0910-AD47
Proposed Rule on Labeling Requirements for OTC Human Drugs
1998 N-0337C; RIN No. 0910-AD-47
Proposed Rule on Labeling Requirements for OTC Human Drugs (request for extension)
2004P-0464
Proposed Rule on Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
76N-052N
OTC Monograph for Nasal Decongestant Drug Products
"Efficacy Meta-Analysis of Single Does 10 mg Phenylephrine vs. Placebo in Adults with Acute Nasal Congestion Due to Common Cold" (Part 1 and Part 2)Memo From Michael StotoLetter from Dallas E. Johnson
NOTE TO PRESS: CHPA is offering a "media kit" with background information and presentations for the December 14, 2007 NDAC meeting
2005N-0403 / RIN 0910-AA49
Request for Extension of Comment Period on the Proposed Rule "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs"
CHPA request to FDA for time on September 25 to address NDAC; CHPA's letter to NDAC; and "Outcomes from the CHPA-FDA Consumer Behavior Roundtable"
1998N-0359
Request for Comments on the Program Priorities in the Center for Food Safety and Applied Nutrition
2005N-0097
1981N-0033; Comment Number C76
Designing a Protocol to Address the Safety and Effectiveness of Benzocaine for the Relief of Toothache PainRevised Final Protocol - Benzocaine Gel Toothache Dose-Resonse Study
DEA-266P
CHPA's Nomination for Industry Liaison Representative to the Nonprescription Drugs Advisory Committee; Resume
FDA Request for Comments on Advance Notice of Proposed Rulemaking, "Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product"
205D-0240
05-006N
U.S. Government draft positions for the Codex Committee on Nutrition and Foods for Special Dietary Uses
Statement of Record Re: Comprehensively Combating Methamphetamines: Impacts on Health and the Environment
2005D-0062
Draft Guidance for Industry on the Food and Drug Administration's "Drug Watch" for Emerging Drug Safety Information
2005D-0240
CHPA Comments and Slide Presentation Before the Institute of Medicine of the National Academies Committee on Identifying and Preventing Medication Errors
Nomination for a Nonvoting Member Representing Industry Interests on the Food Advisory Committee
05-0001N
U.S. Government Positions in Preparation for the 33rd Session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission
Solicitation of Written Comments on the Premarket Notification for New Dietary Ingredient Notifications
Joint Submission to European Commission on 6% Hydrogen Peroxide Tooth Whitening Products
81N-0033
Benzocaine-Containing Products for the Temporary Relief of Toothache Pain
Request for Extension of Comment Period: Premarket Notifications for New Dietary Ingredients
Solicitation of Written Comments on Proposed Definition of Bioactive Food Components
DEA-211P
Proposed Rule: Security Requirements for Manufacturers, Distributors, Importers, and Exports of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
Proposed Rule: Security Requirements for Handlers of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
2004N-0267
Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications, Proposed Rule
Comments on Proposed Revisions to the Proposition 65 Prioritization Procedure
Security Requirements for Manufacturers, Distributors, Importers, and Exporters of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
Industry Coalition on 21 CFR Part 11 Citizen Petition
U.S. Government Position Re: Codex Committee on Nutrition and Foods for Special Dietary Uses
Program Priorities in the Center for Food Safety and Applied Nutrition: Request for Comment
2003N-0342; RIN 0910-AC35
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products, Proposed Rule
1994P-0390 and 1995P-2041
Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Reopening of Comment Period
2003N-0539
FHWA-2004-17321
Specific Service and General Service Signing for 24-Hour Pharmacies
Industry Coalition on Part 11 (presentation at FDA Part 11 Public Meeting)
2004D-0027
Draft Guidance for Industry on Time and Extent Applications
DEA-239T
2003N-0496
96N-0417
1978-036L, RIN 0910-AA01
Laxative Drug Products for OTC Human Use; Reopening of the Administrative Record (attachment)
Comments with Respect to the Annual National Trade Estimate Report on Foreign Trade Barriers
81N-033P
Proposed Monograph on OTC Antigingivitis / Antiplaque Drug Products (Appendix I; Appendix II, Appendix III)
External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record and Amendment of Tentative Final Monograph
Safety Reporting Requirements for Human Drug and Biological Products
Notice of Eligibility; Request for Data and Information (Sunscreen Ingredients)
03-024N
78N-0038
Petition Seeking Permission To Use Truthful Labeling For High SPF Sunscreen Products
Petition for Inclusion of Anti-Aging Claims in the Sunscreen Drug Products for Over-the-Counter Use Final Monograph
Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Dietary Ingredients and Dietary Supplements
Amicus Brief Re: FDA’s Requirement for Specific Warning Language on OTC Nicotine Replacement Therapy Drugs Take Precedence Over a California Court of Appeal's Decision that a Proposition 65 Warning Must Appear on Such Products
Oral Health Care Drug Products for Over-the-Counter Human Use: Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph
2003N-0201
Evaluating Drug Names for Similarities
Evaluating Drug Names for Similarities; Methods and Approaches (meeting formerly called Minimizing Medication Errors-Methods for Evaluating Proprietary Names for Their Confusion Potential); Public Meeting; Request for Comments
02N-0277
02N-0204
FDA Proposed Rule on Bar Code Label Requirements for Human Drug Products and Blood
03N-0069
FDA Task Force on Consumer Health Information for Better Nutrition
98N-0044
03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, 00D-1539
Draft Guidance for Industry on "Part 11, Electronic Records, Electronic Signatures-Scope and Application"; Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Document and a Compliance Policy Guide
02N-0276
02N-0278
FDA Adoption of a Forced Switch Policy
02N-0209
Request for Comment on First Amendment Issues
02N-0276, 02N-0277, 02N-0278, 02N-0275
2002 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188)
98N-0359
2003 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition
02-022N
02N-0058
Pediculicide Drug Products for OTC Human Use
RIN 1515-AD05
Conditional Release Period and Customs Bond Obligations for Food, Drugs, Devices, and Cosmetics
Comments at FDA's Public Meeting on Call on Bar Code Requirements for Human Drug Products
Petition for Stay of Action and Reconsideration of Effective Date of a Technical Amendment to the Final Monograph for Sunscreen Drug Products for Over-the-Counter Human Use
80N-0042
OTC Anticaries Drug Products: Use of Intraoral Appliance Models for Compliance with Biological Testing Requirements; Request for Information and Comments
CHPA Comments on FDA's July 26 Public Meeting on Bar Code Label Requirements for Human Drug Products
98N-0337; 96N-0420; 95N-0259; 90P-0201
Over the Counter Drugs: Labeling Requirements: Partial Delay of Compliance
8IN-003 Comment No. PR5
98N-0583
Petition for Stay of Action on "Exports: Notification and Recordkeeping Requirements"
CHPA Comments to HHS' Advisory Committee on Regulatory Reform
01N-0397
Second Follow-Up Submission by CHPA to the FDA/NTSB Joint Public Meeting on Transportation Safety and Potentially Sedating or Impairing Medications: Comments on the Safety of OTC Antihistamines and OTC Labeling
81N-0114
Comments on Benzoyl Peroxide
Comments with Respect to the National Trade Estimate Report on Foreign Trade Barriers, 66 Fed.Reg. 60237 (12/3/01)
FDA/NTSB Joint Public Meeting on Transportation Safety and Potentially Sedating or Impairing Medications: Comments on the Safety of OTC Antihistamines and OTC Labeling
CHPA Comments to the Institute of Medicine on the Scientific Framework for Safety Evaluation of Dietary Supplements
2002 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition
Comments to the Institute of Medicine's Food and Nutrition Board on Their Proposed Definition for Dietary Fiber
01D-0058
Comments on Guidance on Applying the Structure/Function Rule; Request for Comments
98P-0610
Comments on FDA's Background Materials Relating to May 11, 2001, Joint Meeting of the Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee
CHPA Comments to White House Commission on CAMP on Information Development and Dissemination
CHPA Oral Testimony to the White House Commission on CAMP: Minnesota Town Hall Meeting
00D-1584
Guidance for Industry: Labeling of OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals; Availability Published in Federal Register December 19, 2000
Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body: Availability of Citizen Petitions for Comment
76N-052H
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Use; Reopening of the Administrative Record for Antihistamine Drug Products
Child-Resistant Packaging for Certain OTC Drug Products; Notice of Proposed Rulemaking
78N-036L
CHPA’s Laxative Task Group’s Comments on Psyllium
00D-1392
Guidance for Industry: Botanical Drug Products: Drug Guidance
00N-1200
81N-0022 and 76N-052N
Background Information on Phenylpropanolamine
98N-0337, 96N-0420, 95N-2059 and 90P-0201
OTC Drugs: Labeling Requirements: Partial Extension of Compliance Dates
Sunscreen Drug Products for OTC Human Use; Monograph; Extension of Effective Date; Reopening of Administrative Record
2001 Program Priorities for Dietary Supplements in the Center for Food Safety and Applied Nutrition
00N-1256
OTC Drug Products: Request for Comments
CHPA Comments on the Safety Evaluation of Ephedra
8/8-9/2000
CHPA Presentations at FDA OTC Hearing: Over-the-Counter Medications: A Success Story; Legal Perspective; Scientific/Regulatory Perspective on Rx-to-OTC Switch
6/28-29/2000
Citizen Petition Asking FDA to Establish a Regulation to Define Labeling Requirements for Dietary Supplements Containing St. John’s Wort
Over-the-Counter Drug Products Public Hearing
CHPA Phenylpropanolamine Working Group Comments on Yale Hemorrhagic Stroke Project Report
Citizen Petition to Amend Final Regulation on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body
00N-0598
Comments on “Food Labeling; Dietary Supplement Health Claims; Public Meeting Regarding Pearson Health Claims”
Comments on FDA’s Request for Input on Changes to the Agency’s General Health Claim Regulations for Dietary Supplements that May Be Warranted in Light of the Court Decision in Pearson v. Shalala
FDA Proposal to Revise the Citizen Petition Regulation
99D-5424
Comments on “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Availability”
Draft Guidance for Industry Labeling OTC Human Drug Products Using a Column Format
98N-0337, 96N-0420, 95N-0259, 90P-0201
OTC Label Rule
99N-4235
99N-1819
CHPA Comments to FDA on the Labeling of Topical Antifungal Drug Products for OTC Human Use
CHPA Comments to FDA on CFSAN’s Program Priorities for the Year 2000
CHPA Request to FDA for Extension for Submitting Comments on CFSAN’s Program Priorities
99N-1174
Stakeholder Input on CFSAN’s Overall Strategic Plan for Dietary Supplements
Regulations on Statements for Dietary Supplements Concerning Structure/Function of the Body
99N-0391
CHPA Comments on Codex Vitamin/Mineral Background Paper
Stakeholder input on FDA strategy for dietary supplements
99N-0554
How to Use Health Claims and Nutrient Content Claims in Food Labeling
99N-0386
Talking with Stakeholders about FDA Modernization
80N-0228
CHPA Comments on Oral Discomfort Over-the-Counter Drug Products
98N-0826
Use of Dietary Supplements of Health Claims Based on Authoritative Statements
98P-0043
Food Labeling: Nutrition Labeling of Dietary Supplements on a “Per Day” Basis
Update on Safety Studies with Benzoyl Peroxide
98N-0148
International Drug Scheduling: Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Ephedrine, Dihydroetorphine, Remifentanil and Certain Isomers.
98N-0750
Electronic Reporting of Postmarketing Adverse Drug Reactions.
CHPA comments on HHS Healthy People 2010 Objectives.
98D-0362
Draft guidance for industry on stability testing of drug substances and drug products.
98N-004
Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body.
Reclassification of Bisacodyl as a Category I (generally recognized as safe and effective) active ingredient to Category III (further testing is required).
Stimulant laxative ingredient bisacodyl -- study reports and protocol.
98N-0339
FDA Modernization Act -- questions posed by the agency to best meet objectives in the modernization plan.
Proposed amendment to the tentative final monograph for laxative drug products.
Regarding July 15 feedback meeting on sodium phosphate enemas.
Petition for reconsideration of portions of Final Rule on package size limitations for sodium phosphates oral solution; warning and directions statements for oral and rectal sodium phosphates for OTC laxative use; petition for stay of action of effective date of those portions.
96N-0420, 92N-454A, 90P-0201, 95N-0259
OTC proposed rule on labeling requirements; package size exemption
Comments to Office of U.S. Trade Representative regarding the U.S. and European Union Transatlantic Economic Partnership
88N-004
Request for feedback meeting on Nonprescription Drugs Advisory Committee 9/11/98 meeting on pediatric labeling, dosages and dosage forms for cough/cold products
98N-0056
Pediatric exclusivity eligibility under FDA Modernization Act
98N-0002
Proposed Amendment to Ophthalmic Final Monograph
Documents relating to Dental Plaque Subcommittee Meeting of 5/27-29/98
Testing standards for OTC drugs treating oral discomfort
Draft list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population
Proposed OTC labeling requirements: listing of active and inactive ingredients
Comments on FDA’s Study A (OTC labeling)
OTC label content and format: Package size exemption
80N-0476, 78N-0301, 78N-0021, 78N-0183
OTC vaginal douche products
OTC drug labeling survey
77N-094W
Proposed Alcohol Warning for Analgesic/Antipyretic drugs
97N-0128
Labeling of diphenhydramine-containing OTC’s
81N-0112
Benzoyl peroxide study
OTC antiplaque/antigingivitis combination products
Proposed OTC labeling requirements
97N-0201
OTC label consumer surveys
Proposed OTC labeling requirements (NDAC)
97P-0233/CP1
lead/calcium
97P-0034/CP1
81N-0022
Proposed OTC labeling content and format
International harmonization of chemical safety and health information
OTC drug labeling and MaPPs and procedures
Proposed OTC label requirements -- 90-day extension request
Pseudoephedrine, methamphetamine, ephedrine, phenylpropanolamine
80N-0280
90N-0309, 95N-0254
Bisacodyl Phenolphthalein
96N-0277
ANPR - OTC Monographs and foreign marketing data
Nonoxynol-9 Octoxynol-9
OTC vaginal contraceptives: spermicides
95N-0362
CGMP -- finished pharmaceuticals
95N-0254
90N-0309
Sodium, calcium, magnesium, potassium
95N-0062
Bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, polymyxin B sulfate
95N-0060
92N-454A
OTC labeling -- interchangeable terms
78N-036D
90N-0134
95N-0282
95N-0347
95N-0245
78N-0065
95N-0205
Pseudoephedrine/ephedrine
95N-0259
OTC labeling -- improving communications of information
OTC labeling -- even easier to use labels
82N-0165
75N-0357
91P-0186 and 93P-0306
92N-0311
OTC labeling -- Principal Display Panel
Letter to Rubel Re: CPSC/Coalition for Responsible Packaging Meeting
Letter to Semple Re: CPSC/Coalition for Responsible Packaging Meeting
4/10-13/95
93D-0403
Supplements to new drug applications
88N-0004
Pediatric dosing schedules
Rx-to-OTC switch of muscle relaxants
75N-0244
Acetaminophen/diphenhydra-mine
93N-0182
Aspirin & Non-aspirin salicylates
78N-36D
93N-0181
OTC Antipyretic/analgesic dosing schedules
The nonprescription drug and dietary supplement industries are closely regulated, primarily by the U.S. Food and Drug Administration (FDA). CHPA regularly submits comments to FDA on a wide range of regulatory issues, as well as information to other government agencies and institutions on a host of subjects. This area lists many of the documents submitted by CHPA to government entities during the past several years.
For more information about any of the submissions, CHPA members can contact CHPA's Regulatory and Scientific Affairs Department at 202.429.9260. Copies of FDA FDA-related submissions can also be obtained by visiting FDA's Division of Dockets Management online or writing to:
U.S. Food and Drug AdministrationDivision of Freedom of InformationRoom 12A-305600 Fishers LaneRockville, MD 20857
In your letter to FDA, include the docket number, ingredient or topic, and date of submission. For information on how to receive copies of submissions to the U.S. Drug Enforcement Administration (DEA), visit the DEA's Electronic Reading Room.	Copyright 2012, Consumer Healthcare Products Association. All Rights Reserved.