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DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2004 |
Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999 Draft Guidances |
| January | February | March | April | May | June | July | August | September | October | November |
DecemberVol. 69 (December 20, 2004): Docket No. 2004D-0524. Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Informationl; Availability. Pages 75987-75988 [FR Doc. 04-27736] [ TXT ] [ PDF ] Comments due March 21, 2005 Vol. 69 (December 9, 2004): Docket No. 2004G-0381. Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability. Pages 71656-71657 [FR Doc. 04-26931] [ TXT ] [ PDF ] Comments due January 24, 2005 Vol. 69 (December 9, 2004): Docket No. 2004D-0327. Draft Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability. Pages 71420-71421 [FR Doc. 04-26993] [ TXT ] [ PDF ] Comments due February 7, 2005 NovemberVol. 69 (November 29, 2004): Docket No. 2004D-0484. Draft Guidance for Industry on the Role of human Immunodeficiency Virus Drug Resistance Testing in Antiretroviral Drug Development; Availability. Pages 69374-69375 [FR Doc. 04-26272] [ TXT ] [ PDF ] Comments on draft guidance by February 28, 2005 Vol. 69 (November 26, 2004): Docket No. 2004D-0510. Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association. Pages 68948-68949 [FR Doc. 04-26139] [ TXT ] [ PDF ] Comments by December 27, 2004 Vol. 69 (November 26, 2004): Docket No. 2004D-0509. Draft Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association. Pages 68946-68947 [FR Doc. 04-26138] [ TXT ] [ PDF ] Comments on draft guidance by December 27, 2004 Comments on collection of information by January 25, 2005 Vol. 69 (November 24, 2004): Docket No. 2004D-0369. Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varities Intended for Food Use; Availability. Pages 68381-68383 [FR Doc. 04-26049] [ TXT ] [ PDF ] Comments on draft guidance by January 24, 2005 Vol. 69 (November 17, 2004): Docket No. 2004D-0499. Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Availability. Pages 67360-67361 [FR Doc. 04-25527] [ TXT ] [ PDF ] Comments due November 17, 2005 Vol. 69 (November 10, 2004): Docket No. 2004D-0468. Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals; Availability. Pages 65202-65203 [FR Doc. 04-24995] [ TXT ] [ PDF ] Comments due January 24, 2005 Vol. 69 (November 9, 2004): Docket No. 2004D-0465. Draft Guidance for Food and Drug Administration Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability. Pages 64958-64959 [FR Doc. 04-24879] [ TXT ] [ PDF ] Comments on draft guidance by February 7, 2005 Vol. 69 (November 4, 2004): Docket No. 2004D-0460. Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of Abbreviated New Drug Applications and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003--Questions and Answers; Availability. Pages 64314-64315 [FR Doc. 04-24675] [ TXT ] [ PDF ] Comments on draft guidance due February 2, 2005 Vol. 69 (November 1, 2004): Docket No. 2004D-0459. Draft Guidance for Industry on Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and Impact on Dosing and Labeling. Pages 63402-63403 [FR Doc. 04-24308] [ TXT ] [ PDF ]Comments on draft guidance by January 3, 2005 The Draft Guidance PDF Version OctoberVol. 69 (October 29, 2004): Docket No. 2004D-04539. Draft Revised Compliance Policy Guide Sec. 560.400--Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05); Availability. Pages 63158-63159 [FR Doc. 04-24153] [ TXT ] [ PDF ] Comments due November 29, 2004 Vol. 69 (October 28, 2004): Docket No. 2004D-0462. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes; Availability. Pages 62903-62904 [FR Doc. 04-24066] [ TXT ] [ PDF ] Comments on draft guidance due by January 26, 2005 Vol. 69 (October 4, 2004): Docket No. 2004D-0443. Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability. Page 59256 [FR Doc. 04-22206] [ TXT ] [ PDF ] Comments due December 3, 2004 Vol. 69 (October 4, 2004): Docket No. 2004D-0431. Draft Guidance for Industry and the Food and Drug Administration; Current Good Manufacturing Practices for Combination Products; Availability. Page 59239 [FR Doc. 04-222205] [ TXT ] [ PDF ] Comments due December 3, 2004 Vol. 69 (October 4, 2004): Docket No. 2004D-0440. Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability. Pages 59239-59240 [FR Doc. 04-22204] [ TXT ] [ PDF ] Comments due January 3, 2005 SeptemberVol. 69 (September 28, 2004): Docket No. 2004D-0422. Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability. Pages 57941-57942 [FR Doc. 04-21677] [ TXT ] [ PDF ] Comments due October 28, 2004 The Draft Guidance PDF Version Vol. 69 (September 28, 2004): Docket No. 2004D-0410. Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products; Availability. Pages 57942-57943 [FR Doc. 04-21673] [ TXT ] [ PDF ] Comments due November 29, 2004 Vol. 69 (September 13, 2004): Docket No. 2004D-0378. International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability. Pages 55164-55165 [FR Doc. 04-20564] [ TXT ] [ PDF ] Comments on draft guidance by December 13, 2004 Vol. 69 (September 13, 2004): Docket No. 2004D-0377. International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability. Pages 55163-55164 [FR Doc. 04-20565] [ TXT ] [ PDF ]Comments on draft guidance by December 13, 2004 AugustVol. 69 (August 30, 2004): Docket No. 2004D-0343. Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability. Page 52907 [FR Doc. 04-19656] [ TXT ] [ PDF ] Comments by November 29, 2004 Vol. 69 (August 23, 2004): Docket No. 2003D-0391. Draft Guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys; Availability. Pages 51854-51855 [FR Doc. 04-19179] [ TXT ] [ PDF ] ] Comments due August 23, 2005
Vol. 69 (August 3, 2004): Docket No. 2004D-0283. Draft Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability. Pages 46553-46555 [FR Doc. 04-17627] [ TXT ] [ PDF ] Comments on draft guidance due October 18, 2004 Agency Information Collection October 4, 2004 JulyJuneVol. 69 (June 3, 2004): Docket No. 2004D-0251. Draft Guidance for Industry, Food and Drug Administration Staff, and Food and Drug Administration-Accredited Third-Parties: Requests for Inspection by an Accredited Person Under the Inspections by Accredited Persons Program Authorized by the Medical Device User Fee and Modernization Act of 2002; Availability. Pages 31397-31398 [FR Doc. 04-12683] [ TXT ] [ PDF ] Comments due September 1, 2004 Vol. 69 (June 1, 2004): Docket No. 2004D-0042. Draft Guidances for Industry on Improving Information About Medical Products and health Conditions; Availability; Reopening of Comment Period. Page 30945 [FR Doc. 04-12270] [ TXT ] [ PDF ] Comments on guidance by August 10, 2004 MayVol. 69 (May 25, 2004): Docket No. 2004D-0193. Draft "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" Availability. Pages 29834-29835 [FR Doc. 04-11246] [ TXT ] [ PDF ] Comments by August 23, 2004 Vol. 69 (May 21, 2004): Docket No. 2003D-0538. Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Actions on Premarket Notification Submissions: Effect on Food and Drug Administration Review Clock and Performance Assessment; Availability. Pages 29314-29315 [FR Doc. 04-11503] [ TXT ] [ PDF ] Vol. 69 (May 12, 2004): Docket No. 2004D-0198. Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components; Availability (Notice). Page 26399 [FR Doc. 04-10753] [ TXT ] [ PDF ] Comments due August 10, 2004 Vol. 69 (May 5, 2004): Docket Nos. 2004D-0189, 2004D-0187, 2004D-0188. Draft Guidances for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability. Pages 25130-25132 [FR Doc. 04-10028] [ TXT ] [ PDF ] Comments due July 6, 2004
Vol. 69 (May 4, 2004): Docket No. 2004D-0182. Draft Guidance for Industry on Combination Products, Timeliness of Premarket Reviews, Dispute Resolution; Availability. Pages 24653-24654 [FR Doc. 04-10027] [ TXT ] [ PDF ] Comments on guidance by July 6, 2004 Vol. 69 (May 3, 2004): Docket No. 2004D-0065. Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2); Availability. Pages 24070-24071 [FR Doc. 04-10023] [ TXT ] [ PDF ] Comments by May 3, 2005 AprilVol. 69 (April 28, 2004): Docket No. 2003D-0206. Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications; Availability. Pages 23413-23414 [FR Doc. 04-09653] [ TXT ] [ PDF ] Comments on draft guidance due June 24, 2004 Vol. 69 (April 28, 2004): Docket No. 2004D-0146. Draft Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds. Page 23209 [FR Doc. 04-09566] [ TXT ] [ PDF ] Comments on draft guidance July 12, 2004 Vol. 69 (April 21, 2004): Docket No. 2004D-0156. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Environmental Impact Assessments for Veterinary Medicinal Products--Phase II; Request for Comments; Availability. Pages 21552-21553 [FR Doc. 04-09071] [ TXT ] [ PDF ] Comments on guidance due May 21, 2004 MarchVol. 69 (March 30, 2004): Docket No. 2004D-0118. International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; Availability. Pages 16580-16581 [FR Doc. 04-07104] [ TXT ] [ PDF ] Comments on draft guidance by May 19, 2004 Vol. 69 (March 30, 2004): Docket No. 2004D-0117. International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning; Availability. Pages 16579-16580 [FR Doc. 04-07105] [ TXT ] [ PDF ] Comments on draft guidance by May 19, 2004 Vol. 69 (March 17, 2004): Docket No. 2004D-0071. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices; Availability. Pages 12701-12702 [FR Doc. 04-05979] [ TXT ] [ PDF ] Comments by June 15, 2004 Vol. 69 (March 9, 2004): Docket No. 2003D-0553. Draft Guidance for Industry on Vaccinia Virus --Developing Drugs to Mitigate the Complications Associated With Vaccinia Virus Used for Smallpox Vaccination; Availability. Pages 11024-11025 [FR Doc. 04-05241] [ TXT ] [ PDF ] Comments due May 10, 2004 Vol. 69 (March 5, 2004): Docket No. 2000D-1350. Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability. Pages 10457-10458 [FR Doc. 04-04886] [ TXT ] [ PDF ] Comments by May 4, 2004 FebruaryVol. 69 (February 25, 2004): Docket No. 2003D-0568. Draft Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices; Availability. Pages 8667-8668 [FR Doc. 04-03859] [ TXT ] [ PDF ] Comments on guidance by May 25, 2004 Vol. 69 (February 17, 2004): Docket No. 1998D-0834. Draft Guidance for Industry on Labeling for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Prescribing Information for Health Care Providers and Patient Labeling; Availability. Pages 7492-7493 [FR Doc. 04-03330 ] [ TXT ] [ PDF ] Comments due April 19, 2004 Vol. 69 (February 11, 2004): Docket No. 2004D-0035. Draft Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis; Request for Comments. Pages 6673-6674 [FR Doc. 04-02999] [ TXT ] [ PDF ] Comments by April 12, 2004 Vol. 69 (February 10, 2004): Docket No. 2004D-00277. Draft Guidance for Industry on Time and Extent Applications; Availability. Pages 6309-6310 [FR Doc. 04-02729] [ TXT ] [ PDF ] Written comments on guidance April 12, 2004 Vol. 69 (February 10, 2004): Docket No. 2004D-0042. Draft Guidances for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability. Pages 6308-6309 [FR Doc. 04-02728] [ TXT ] [ PDF ]Written comments on guidances May 10, 2004
Vol. 69 (February 5, 2004): Docket No. 2004D-0041. Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling; Availability. Pages 5552-5553 [FR Doc. 04-02536] [ TXT ] [ PDF ] Comments on draft guidance due April 5, 2004 JanuaryVol. 69 (January 27, 2004): Docket No. 2004D-0014. Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Availability. Pages 3923-3925 [FR Doc. 04-01591] [ TXT ] [ PDF ] Comments on draft guidance by March 29, 2004 Vol. 69 (January 14, 2004): Docket No. 2003D-0558. Draft Compliance Policy Guide, Guidance Levels for Radionuclides in Domestic and Imported Foods, Availability; and Draft Supporting Document, Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods, Availability. Pages 2146-2147 [FR Doc. 04-00719] [ TXT ] [ PDF ] Comments due March 15, 2004
Vol. 69 (January 13, 2004): Docket No. 2004D-0002. Draft Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants, Availability. Pages 1988-1989 [FR Doc. 04-658] [ TXT ] [ PDF ] Comments due April 12, 2004 Vol. 69 (January 12, 2004): Docket No. 2003D-0545. Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities; Availability. Page 1675 [FR Doc. 04-598] [ TXT ] [ PDF ] Comments due January 12, 2005 Vol. 69 (January 7, 2004): Docket No. 2003D-0571. Draft Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information; Availability. Pages 929-930 [FR Doc. 04-00259] [ TXT ] [ PDF ] Electronic Comments by July 6, 2004 |
Page created September 24, 2003 jb
Page updated
August 1, 2006
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