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DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2005 |
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. 70 (December 27, 2005): Docket No. 2005D-0490. Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2); Availability. Page 76463 [FR Doc. E5-07803] [ TXT ] [ PDF ] Comments due December 27, 2006 Vol. 70 (December 27, 2005): Docket No. 2005D-0481. Draft Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy; Draft Supporting Document: Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small Children; Availability. Page 76462 [FR Doc. 05-24494] [ TXT ] [ PDF ] Comments due March 13, 2006 Vol. 70 (December 8, 2005): Docket No. 2005D-0434. Draft Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens; Availability. Pages 73010-73011 [FR Doc. 05-23746] [ TXT ] [ PDF ] Comments due March 8, 2006 The Draft Guidance PDF Version Vol. 70 (December 1, 2005): Docket No. 2005D-0438. Draft Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Availability. Pages 72124-72125 [FR Doc. 05-23520] [ TXT ] [ PDF ] Comments by March 1, 2006 NovemberVol. 70 (November 16, 2005): Docket No. 1998D-0834 (formerly Docket No. 98D-0834). Draft Guidance for Industry on Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Information for Health Care Providers and Patient Labeling; Availability. Pages 69578-69579 [FR Doc. 05-22754] [ TXT ] [ PDF ] Comments due January 17, 2006 Vol. 70 (November 14, 2005): Docket No. 2004D-0555. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex; Availability. Pages 69156-69160 [FR Doc. 05-22610] [ TXT ] [ PDF ] [ PRE-PUB ] Comments by February 13, 2006 Vol. 70 (November 8, 2005): Docket No. 2005D-0344. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tinnitus Masker Devices; Availability. Pages 67724-67725 [FR Doc. 05-22268] [ TXT ] [ PDF ] Comments on draft guidance by February 6, 2006 OctoberVol. 70 (October 20, 2005): Docket No. 2005D-0362. Draft Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin Antibodies; Availability. Pages 60035-61136 [FR Doc. 05-20958] [ TXT ] [ PDF ] Comments on draft guidance by January 18, 2006 Vol. 70 (October 11, 2005): Docket No. 2005D-0401. Draft Guidance for Industry and FDA Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability. Pages 59074-59075 [FR Doc. 05-20329] [ TXT ] [ PDF ] Comments by November 10, 2005 Vol. 70 (October 6, 2005): Docket No. 2005D-0391. Draft Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrilators; Availability. Pages 58447-58448 [FR Doc. 05-20092] [ TXT ] [ PDF ] Comments due January 4, 2006 The Draft Guidance Vol. 70 (October 3, 2005): Docket No. 2005D-0330. Draft Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods; Availability. Pages 57609-57610 [FR Doc. 05-19727] [ TXT ] [ PDF ] Comments due January 3, 2006 SeptemberVol. 70 (September 30, 2005): Docket No. 2005D-0385. Draft Guidance for Industry on Using Electronic Means to Distribute Certain Product Information; Availability. Pages 57300-57301 [FR Doc. 05-19731] [ TXT ] [ PDF ] Comments due November 29, 2005 Vol. 70 (September 19, 2005): Docket No. 2005D-0340. Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment; Availability. Pages 54945-54946 [FR Doc. 05-18512] [ TXT ] [ PDF ] Comments on draft guidance by December 19, 2005 Vol. 70 (September 15, 2005): Docket No. 2005D-0348. Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability. Pages 54561-54562 [FR Doc. 05-18372] [ TXT ] [ PDF ] Comments on draft guidance by November 14, 2005 Vol. 70 (September 7, 2005): Docket No. 2005D-0334. Draft Guidance for Industry on the Pediatric Research Equity Act; Availability. Pages 53233-53235 [FR Doc. 05-17694] [ TXT ] [ PDF ] Comments due November 7, 2005 Vol. 70 (September 6, 2005): Docket No. 2005D-0324. International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability. Pages 53021-53022 [FR Doc. 05-17597] [ TXT ] [ PDF ] Comments due October 21, 2005 The Draft Guidance PDF Version AugustVol. 70 (August 29, 2005): Docket No. 2005D-0312. Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability. Page 51077 [FR Doc. 05-17150] [ TXT ] [ PDF ]Comments due November 28, 2005 Vol. 70 (August 8, 2005): Docket No. 2005D-0288. International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management; Availability. Pages 45722-45723 [FR Doc. 05-15546] [ TXT ] [ PDF ] Comments due October 7, 2005 JulyVol. 70 (July 27, 2005): Docket No. 2005D-02616. Draft Guidance for Industry on Nucleic Acid Testing for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product Disposition, and Donor Deferral and Reentry; Availability. Pages 43439-43440 [FR Doc. 05-14746] [ TXT ] [ PDF ] Comments due October 5, 2005 Vol. 70 (July 21, 2005): Docket No. 2005D-0274. Draft Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments; Availability. Pages 42072-42075 [FR Doc. 05-14321] [ TXT ] [ PDF ] Comments regarding draft manuals due by September 19, 2005 A Regulator's Manual Vol. 70 (July 15, 2005): Docket No. 2005D-0195, CDRH 200439. Draft Guidance for Industry and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9; Availability. Pages 41043-41045 [FR Doc. 05-13974] [ TXT ] [ PDF ] [ PRE-PUB ] Comments due October 13, 2005 JuneVol. 70 (June 28, 2005): Docket No. 2005D-0240. Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability. Pages 37102-37103 [FR Doc. 05-12764] [ TXT ] [ PDF ] Comments due August 29, 2005 The Draft Guidance PDF Version Vol. 70 (June 20, 2005): Docket No. 2005D-0223. Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability. Pages 35448-35449 [FR Doc. 05-12040] [ TXT ] [ PDF ] Comments due September 19, 2005 Vol. 70 (June 7, 2005): Docket No. 2005D-0202. Draft Guidance for Industry on Bar Code Label Requirements--Questions and Answers; Availability. Pages 33182-33183 [FR Doc. 05-11266] [ TXT ] [ PDF ] Comments on draft guidance due August 8, 2005 MayVol. 70 (May 31, 2005): Docket No. 2005D-0174. Draft Guidance on Expiration Dating of Unit-Dose Repackaged Drugs; Availability. Page [FR Doc. ] [ TXT ] [ PDF ] Comments due August 29, 2005 The Draft Guidance PDF Version Vol. 70 (May 27, 2005): Docket No. 2005D-0200. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products; Request for Comments; Availability. Pages 30763-30764 [FR Doc. 05-10625] [ TXT ] [ PDF ] Vol. 70 (May 27, 2005): Docket No. 2005D-0199. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH): Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances; Request for Comments; Availability. Pages 30761-30763 [FR Doc. 05-10624] [ TXT ] [ PDF ] Vol. 70 (May 26, 2005): Docket No. 2005D-0169. Draft Guidance on Useful Written Consumer Medication Information. Pages 30467-30469 [FR Doc. 05-10445] [ TXT ] [ PDF ] Comments on draft guidance by July 25, 2005 Vol. 70 (May 25, 2005): Docket No. 2005D-0183. Draft Guidance for Industry on Antiviral Drug Development--Conducting Virology Studies and Submitting the Data to the Agency; Availability, Draft Guidance for Industry on Antiviral Drug Development--Conducting Virology Studies and Submitting the Data to the Agency; Availability. Pages 30127-30128 [FR Doc. 05-10431] [ TXT ] [ PDF ] Comments by July 25, 2005 Vol. 70 (May 10, 2005): Docket No. 2005D-0062. Draft Guidance for Industry on the Food and Drug Administration's Drug Watch for Emerging Drug Safety Information; Availability. Pages 24606-24607 [FR Doc. 05-9297] [ TXT ] [ PDF ] Comments on draft guidance due August 8, 2005 Vol. 70 (May 2, 2005): Docket No. 2005D-0155. Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; Availability. Pages 22664-22665 [FR Doc. 05-08634] [ TXT ] [ PDF ] Comments by August 1, 2005 AprilVol. 70 (April 20, 2005): Docket No. 2005D-0133. Draft Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection; Availability. Pages 20575-20576 [FR Doc. 05-07821] [ TXT ] [ PDF ] Comments due May 20, 2005 Vol. 70 (April 18, 2005): Docket No. 2005D-0091. Draft Guidance for Industry on User Fee Waivers for Fixed Dose Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability. Pages 20145-20146 [FR Doc. 05-07729] [ TXT ] [ PDF ] Comments due June 17, 2005 The Draft Guidance PDF Version Vol. 70 (April 14, 2005): Docket No. 2005D-0122. Draft Guidance for Industry on Exploratory Investigational New Drugs Studies; Availability. Pages 19764-19765 [FR Doc. 05-07485] [ TXT ] [ PDF ] Comments on guidances by July 13, 2005 Vol. 70 (April 4, 2005): Docket No. 2005D-0112. Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability. Page 17095 [FR Doc. 05-6647] [ TXT ] [ PDF ] Comments due June 3, 2005 The Draft Guidance PDF Version MarchVol. 70 (March 28, 2005): Docket No. 2005D-0103. Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials; Availability. Pages 15635-15636 [FR Doc. 05-05977] [ TXT ] [ PDF ] Comments by May 27, 2005 The Draft Guidance PDF version Vol. 70 (March 9, 2005): Docket No. 1993D-0394. Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance. Page 11679 [FR Doc. 05-04633] [ TXT ] [ PDF ] Effective date March 9, 2005 FebruaryVol. 70 (February 24, 2005): Docket No. 2003N-0528. Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability. Page 9084 [FR Doc. 05-03593] [ TXT ] [ PDF ] Comments due May 25, 2005 Vol. 70 (February 18, 2005): Docket No. 2005D-0047. Draft Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability. Pages 8378-8379 [FR Doc. 05-03106] [ TXT ] [ PDF ]Comments on draft guidance by May 19, 2005 Vol. 70 (February 18, 2005): Docket No. 2005D-0043. Blood Pressure Measurement Devices (Sphygmomanometers)--Accuracy; Draft Revised Complicance Policy Guide; Availability. Pages 8377-8378 [FR Doc. 05-03116] [ TXT ] [ PDF ] Comments on draft guidance by May 19, 2005 Vol. 70 (February 15, 2005): Docket No. 2005D-0042. Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability. Page 7747 [FR Doc. 05-02822] [ TXT ] [ PDF ] Comments on draft guidance by June 15, 2005 Vol. 70 (February 15, 2005): Docket No. 2005D-0033. Draft Guidance for Industry on Internal Radioactive Contamination--Development of Decorporation Agents; Availability. Pages 7747-7748 [FR Doc. 05-02821] [ TXT ] [ PDF ] Comments on draft guidance by May 16, 2005 The Draft Guidance PDF version Vol. 70 (February 9, 2005): Docket No. 2005D-0021. International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development; Availability. Pages 6888-6889 [FR Doc. 05-02449] [ TXT ] [ PDF ] Comments due April 11, 2005 Vol. 70 (February 8, 2005): Docket No. 2005D-0030. Draft Guidance for Industry on Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling; Availability. Page 6697 [FR Doc. 05-02416] [ TXT ] [ PDF ] Comments on draft guidance by April 11, 2005 Vol. 70 (February 8, 2005): Docket No. 2005D-0022. International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; Availability. Pages 6697-6698 [FR Doc. 05-02418] [ TXT ] [ PDF ] Comments by April 11, 2005 JanuaryVol. 70 (January 31, 2005): Docket No. 1998D-0514. Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information; Availability. Page 4857 [FR Doc. 05-01752] [ TXT ] [ PDF ] Comments due May 2, 2005 Vol. 70 (January 26, 2005): Docket No. 2005D-0004. Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability. Pages 3714-3715 [FR Doc. 05-01394] [ TXT ] [ PDF ] Comments due April 26, 2005 Vol. 70 (January 13, 2005): Docket No. 2004D-0549. Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability. Pages 2415-2416 [FR Doc. 05-00696] [ TXT ] [ PDF ] Comments on draft guidance by March 14, 2005 |
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Page updated
June 16, 2006
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