Draft Guidances published in 2002

Dockets Management

DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2002

Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999

Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999

Draft Guidances

December

Vol. 67 (December 31, 2002): Docket No. 96D-0041. International Conference on Harmonisation; Draft Guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability. Pages 79939-79940 [FR Doc. 02-32979] [ TXT ] [ PDF ]

Vol. 67 (December 30, 2002): Docket No. 02N-0509. International Conference on Harmonisation; Draft Guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; Availability. Pages 79639-79640 [FR Doc. 02-32852] [ TXT ] [ PDF ] Comments by February 28, 2003

Vol. 67 (December 26, 2002): Docket No. 00P-1378. Draft Guidance for Industry on Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability; Correction. Pages 78810--78811 [FR Doc. 02-32613] [ TXT ] [ PDF ]

Vol. 67 (December 18, 2002): Docket No. 02D-0468. Draft Guidance for Industry on Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores; Availability. Pages 77500--77501 [FR Doc. 02-31721] [ TXT ] [ PDF ] Comments March 3, 2003

Vol. 67 (December 2, 2002): Docket No. 00P-1378. Draft Guidance for Industry on Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability. Pages 71577--71579 [FR Doc. 02-30340] [ TXT ] [ PDF ] Comments due by January 31, 2003

November

Vol. 67 (November 12, 2002): Docket No. 00D-1540. Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records; Availability. Pages 68674--68675 [FR Doc. 02-28551] [ TXT ] [ PDF ] Comments February 10, 2003

Vol. 67 (November 6, 2002): Docket No. 02D-0449. Draft Guidance for Industry: The Administrative New Animal Drug Application Process; Availability. Pages 67631-67632 [FR Doc. 02-28257] [ TXT ] [ PDF ] Comments on the draft guidance by January 21, 2003 Comments on the collection requirements by January 6, 2003

October

Vol. 67 (October 22, 2002): Docket No. 02D-0371. Draft Guidance for Industry on Class II Special Controls Guidance Document: Human Dura Mater; Availability. Pages 64901--64902 [FR Doc. 02-26817] [ TXT ] [ PDF ] Comments January 21, 2003

Vol. 67 (October 18, 2002): Docket No. 02D-0428. Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Availability. Page 64402 [FR Doc. 02-26612] [ TXT ] [ PDF ] Comments December 17, 2002

Vol. 67 (October 18, 2002): Docket No. 02D-0350. Draft Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability; Reopening of Comment Period. Pages 64401--64402 [FR Doc. 02-26475] [ TXT ] [ PDF ] Comments December 17, 2002

Vol. 67 (October 7, 2002): Docket No. 02D-0384. Draft Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing; Availability. Page 62489 [FR Doc. 02-25391] [ TXT ] [ PDF ] Comments December 6, 2002

Vol. 67 (October 7, 2002): Docket No. 02P-0009. Draft Guidance for Industry: Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices; Availability. Pages 62488--62489 [FR Doc. 02-25342] [ TXT ] [ PDF ] Comments December 6, 2002

Vol. 67 (October 4, 2002): Docket No. 01D-0202. Medical Devices: The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles; Availability. Pages 62252-62253 [FR Doc. 02-25195] [ TXT ] [ PDF ] Comments October 4, 2003

Vol. 67 (October 2, 2002): Docket No. 02D-0389. Draft Guidance for Industry on Nonclinical Studies for Development of Pharmaceutical Excipients; Availability. Pages 61910-61911 [FR Doc. 02-24985] [ TXT ] [ PDF ] Comments by December 31, 2002

September

Vol. 67 (September 13, 2002): Docket No. 98D-1146. Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Availability. Pages 58058--58060 [FR Doc. 02-23387] [ TXT ] [ PDF ] Comments November 27, 2002

Vol. 67 (September 12, 2002): Docket No. 02D-0333. Draft Guidance for Industry: Juice HACCP Hazards and Controls Guidance, First Edition; Availability. Page 57829 [FR Doc. 02-23106] [ TXT ] [ PDF ] Comments November 12, 2002

Vol. 67 (September 12, 2002): Docket No. 02D-0324. Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals; Availability. Pages 57828--57829 [FR Doc. 02-23105] [ TXT ] [ PDF ] Comments January 10, 2003 Comment period extended to February 7, 2003

Vol. 67 (September 6, 2002): Docket No. 02D-0325. Medical Devices; Draft Guidance; Medical Devices Made With Polyvinylchloride Using the Plasticizer di-(2-Ethylhexyl)phthalate; Availability. Pages 57026-57027 [FR Doc. 02-22687] [ TXT ] [ PDF ] Comments due December 5, 2002

Vol. 67 (September 5, 2002): Docket No. 00D-1539. Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records; Availability. Pages 56848-56849 [FR Doc. 02-22634] [ TXT ] [ PDF ] Comments by December 4, 2002

Vol. 67 (September 4, 2002): Docket No. 02D-0369. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32) Availability; Request for Comments. Pages 56572-56573 [FR Doc. 02-22407] [ TXT ] [ PDF ] Comments by October 4, 2002

Vol. 67 (September 4, 2002): Docket No. 02D-0326. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Draft Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (VICH GL33); Request for Comments. Pages 56570-56572 [FR Doc. 02-22406] [ TXT ] [ PDF ] Comments by October 4, 2002

Vol. 67 (September 4, 2002): Docket No. 02D-0368. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Draft Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-day) Toxicity Testing (VICH GL31); Request for Comments; Availability. Pages 56569-56570 [FR Doc. 02-22408] [ TXT ] [ PDF ] Comments by October 4, 2002

August

Vol. 67 (August 27, 2002): Docket No. 02D-0320. Draft Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct; Availability. Pages 55025--55026 [FR Doc. 02-21697] [ TXT ] [ PDF ] Comments by November 25, 2002

Vol. 67 (August 21, 2002): Docket No. 02D-0337. Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Availability. Page 54220 [FR Doc. 02-21263] [ TXT ] [ PDF ] Comments due November 19, 2002

Vol. 67 (August 21, 2002): Docket No. 02D-0350. Draft Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability. Pages 54219-54220 [FR Doc. 02-21262] [ TXT ] [ PDF ] Comments due September 20, 2002

Vol. 67 (August 14, 2002): Docket No. 02D-0306. Medical Devices; Class II Special Controls Guidance Document: Dental Sonography Device and the Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers; Availability. Pages 53005--53006 [FR Doc. 02-20500] [ TXT ] [ PDF ] Comments by November 12, 2002

Vol. 67 (August 7, 2002): Docket No. 02D-0307. Draft Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision; Availability. Pages 51284-51285 [FR Doc. 02-19863] [ TXT ] [ PDF ] Comments by September 23, 2002

The Draft Guidance

July

Vol. 67 (July 26, 2002): Docket No. 02D-0254. Draft Guidance for Industry on Inhalation Drug Products Packaged in Semipermeable Container Closure Systems; Availability. Pages 48920--48921 [FR Doc. 02-19020] [ TXT ] [ PDF ]Comments by October 24, 2002

Vol. 67 (July 17, 2002): Docket No. 01D-0064. Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy and Dental Mercury Labeling; Availability. Pages 46991--46992 [FR Doc. 02-17961] [ TXT ] [ PDF ] Comments by September 16, 2002

Vol. 67 (July 11, 2002): Docket No. 02D-0258. Draft Revised Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations; Availability. Page 45983 [FR Doc. 02-17403] [ TXT ] [ PDF ] Comments by August 12, 2002

June

Vol. 67 (June 27, 2002): Docket No. 02D-0260. Draft Guidance for Industry on Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics; Availability. Pages 43330--43331 [FR Doc. 02-16160] [ TXT ] [ PDF ] Comments by September 25, 2002

Vol. 67 (June 25, 2002): Docket No. 02D-0266. Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability. Pages 42789--42790 [FR Doc. 02-15898] [ TXT ] [ PDF ] Comments by December 23, 2002

Vol. 67 (June 14, 2002): Docket No. 02D-0231. International Conference on Harmonisation; Stability Data Package for Registration in Climatic Zones III and IV; Availability. Pages 40951--40952 [FR Doc. 02-14999] [ TXT ] [ PDF ] Comments by August 20, 2002

Vol. 67 (June 14, 2002): Docket No. 02D-0232. International Conference on Harmonisation; Draft Guidance on S7B Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability. Pages 40950--40951 [FR Doc. 02-15000] [ TXT ] [ PDF ]Comments by August 1, 2002

Vol. 67 (June 14, 2002): Docket No. 02D-0237. International Conference on Harmonisation; Draft Guidance on Q1E Evaluation of Stability Data; Availability. Pages 40949--40950 [FR Doc. 02-15001] [ TXT ] [ PDF ] Comments by August 1, 2002

Vol. 67 (June 14, 2002): Docket No. 01D-0435. International Conference on Harmonisation; Draft Guidance on Electronic Common Technical Document Specification; Availability. Pages 40948--40949 [FR Doc. 02-15003] [ TXT ] [ PDF ] Comments by August 1, 2002

Vol. 67 (June 12, 2002): Docket No. 02D-0228. Medical Devices; Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA; Availability. Page 40318 [FR Doc. 02-14839] [ TXT ] [ PDF ] Comments by September 10, 2002

Vol. 67 (June 4, 2002): Docket No. 02D-0124. Draft Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Availability. Pages 38505--38506 [FR Doc. 02-13860 ] [ TXT ] [ PDF ] Comments by September 3, 2002

May

Vol. 67 (May 17, 2002): Docket No. 98D-0388. Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Withdrawal. Pages 35122-35123 [FR Doc. 02-12326] [ TXT ] [ PDF ]

Vol. 67 (May 17, 2002): Docket No. 99D-2635. ANDAs: Blend Uniformity Analysis; Withdrawal of Draft Guidance. Pages 35120-35121 [FR Doc. 02-12359] [ TXT ] [ PDF ]

Vol. 67 (May 14, 2002): Docket No. 02D-0113. Medical Devices; Draft Guidance for Industry and FDA on Class II Special Controls: Root-Form Endosseous Dental Implants and Abutments; Availability. Pages 34458--34459 [FR Doc. 02-12042] [ TXT ] [ PDF ] Comments by August 12, 2002

April

Vol. 67 (April 11, 2002): Docket No. 02D-0081. Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations; Availability. Pages 17704--17705 [FR Doc. 02-08747] [ TXT ] [ PDF ] Comments by July 10, 2002

Vol. 67 (April 9, 2002): Docket No. 02D-0094. Draft Guidance for Industry on IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products; Availability. Page 17078 [FR Doc. 02-08462] [ TXT ] [ PDF ]Comments by June 10, 2002

Vol. 67 (April 9, 2002): Docket No. 02D-0096. Draft "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV;" Availability. Page 17077 [FR Doc. 02-08464] [ TXT ] [ PDF ] Comments by July 8, 2002

Vol. 67 (April 5, 2002): Docket No. 02D-0011. Medical Devices: Draft Guidance on Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA; Availability. Pages 16406-16407 [FR Doc. 02-08348] [ TXT ] [ PDF ] Comments by July 5, 2002

Vol. 67 (April 2, 2002): Docket No. 02D-0095. Draft Guidance for Industry on Exposure-Response Relationships: Study Design, Data Analysis, and Regulatory Applications; Availability. Pages 15576--15577 [FR Doc. 02-07883] [ TXT ] [ PDF ] Comments by June 3, 2002

Vol. 67 (April 1, 2002): Docket No. 98D-0266. Draft Guidance on Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability. Page 15404 [FR Doc. 02-07729] [ TXT ] [ PDF ]

March

Vol. 67 (March 20, 2002): Docket No. 00D-1542. Draft Guidance for Industry on Electronic Records; Electronic Signatures, Time Stamps; Availability. Page 12999 [FR Doc. 02-06623] [ TXT ] [ PDF ] Comments by June 18, 2002

Vol. 67 (March 18, 2002): Docket No. 02D-0002. Draft Guidance for Industry on Developing Drugs to Treat Inhalational Anthrax (Post-Exposure); Availability. Pages 12021-12022 [FR Doc. 02- 06319] [ TXT ] [ PDF ] Comments by May 17, 2002

Vol. 67 (March 7, 2002): Docket No. 02D-0039. Medical Devices; Draft Guidance for Industry and FDA on Premarket Notification Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Availability. Page 10418 [FR Doc. 02-05489] [ TXT ] [ PDF ] Comments by June 5, 2002

February

Vol. 67 (February 21, 2002): Docket No. 02D-0028. Medical Devices; Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance for Industry and FDA; Availability. Pages 8031-8032 [FR Doc. 02-04209] [ TXT ] [ PDF ] ] Comments by April 22, 2002

Vol. 67 (February 20, 2002): Docket No. 02D-0003. Draft Guidance for Industry on Exercise-Induced Bronchospasm (EIB)-Development of Drugs to Prevent EIB; Availability. Page 7704 [FR Doc. 02-04090] [ TXT ] [ PDF ] Comments by April 21, 2002

Vol. 67 (February 20, 2002): Docket No. 01D-0064. Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Availability. Pages 7703--7704 [FR Doc. 02-04029] [ TXT ] [ PDF ] Comments by May 21, 2002

Vol. 67 (February 12, 2002): Docket No. 02D-0049. Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees; Availability. Pages 6545--6546 [FR Doc. 02-03279] [ TXT ] [ PDF ] Comments by March 14, 2002

Vol. 67 (February 12, 2002): Docket No. 01D-0577. Medical Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA; Availability. Pages 6544--6545 [FR Doc. 02-03280] [ TXT ] [ PDF ] Comments by May 13, 2002

Vol. 67 (February 11, 2002): Docket No. 99D-5347. Draft "Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts;". Page 6266 [FR Doc. 02-03200] [ TXT ] [ PDF ] Comments by May 13, 2002

Vol. 67 (February 7, 2002): Docket No. 98D-0729. Medical Devices; Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Availability. Pages 5833--5834 [FR Doc. 02-03020] [ TXT ] [ PDF ] Comments by February 7, 2003

Vol. 67 (February 7, 2002): Docket No. 01D-0582. Draft Guidance for Industry on Available Therapy; Availability. Pages 5831--5832 [FR Doc. 02-02948] [ TXT ] [ PDF ] Comments by April 8, 2002

Vol. 67 (February 7, 2002): Docket No. 91D-0407. Draft Guidance for Industry and FDA on Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Availability. Pages 5832--5833 [FR Doc. 02-03018] [ TXT ] [ PDF ] Comments by May 8, 2002

January

Vol. 67 (January 31, 2002): Docket No. 01D-0584. Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV. Pages 4719--4720 [FR Doc. 02-02321] [ TXT ] [ PDF ] Comments by May 1, 2002

Page created September 24, 2003 jb
Page updated June 16, 2006 jb

FDA/Dockets Management