Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases
of Known or Suspected West Nile Virus Infection.
(29NOV02)
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Guidance |
Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds; Availability.
(27NOV02)
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Medical Devices; Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep
Apnea; Guidance for Industry and FDA; Availability. (12NOV02)
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The Guidance (.doc)
The Guidance (.pdf) |
Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records;
Availability. (12NOV02)
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The Draft Guidance |
Final Guidance for Industry on the Development of Supplemental Applications for Approved New Animal Drugs; Availability.
(08NOV02)
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|
Medical Devices; Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System; Guidance
for Industry and FDA; Availability.
(07NOV02)
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The Guidance (.doc)
The Guidance (.pdf) |
Draft Guidance for Industry: The Administrative New Animal Drug Application Process; Availability. (06NOV02)
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The Draft Guidance (Word) |
Regulatory Procedures Manual; Chapter 9, Imports, Subchapter: Guidance Concerning Recommending Customs' Seizure and
Destruction of Imported Human and Animal Food That Has Not Been Reconditioned; Availability. (05NOV02)
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The Guidance |
Guidance for Industry on Antiretroviral Drugs Using Plasma Human Immunodeficiency Virus Ribonucleic Acid
Measurements--Clinical Considerations for Accelerated and Traditional Approval; Availability. (01NOV02)
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The Guidance--Word
The Guidance--PDF |
Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability. (01NOV02)
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The Guidance
|
Draft Guidance for Industry on Class II Special Controls Guidance Document: Human Dura Mater; Availability. (22OCT02)
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The Draft Guidance PDF |
Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Updating Labeling in Reference Listed Drugs and
Abbreviated New Drug Applications; Availability.
(18OCT02)
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The Guidance |
Draft Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability;
Reopening of Comment Period. (18OCT02)
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Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components;
Availability. (18OCT02)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry on Formal
Dispute Resolution; Appeals Above the Division Level. (16OCT02)
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Diagnostic X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17. (10OCT02)
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The Guidance
|
Guidance on the Petition Process to Request Approval of Labeling for Foods That Have Been Treated By Irradiation;
Availability. (07OCT02)
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The Guidance |
Guidance for Industry: Exemptions From the Warning Label Requirement for Juice--Recommendations for Effectively Achieving
a 5-Log Pathogen Reduction; Availability. (07OCT02)
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The Guidance |
Draft Guidance for Industry: Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices;
Availability. (07OCT02)
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The Draft Guidance |
Draft Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing;
Availability. (07OCT02)
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The Draft Guidance |
Draft Guidance for Industry on Nonclinical Studies for Development of Pharmaceutical Excipients; Availability.
(02OCT02)
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The Draft Guidance |
Guidance for Industry on Establishing Pregnancy Exposure Registries; Availability. (23SEP02)
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The Guidance PDF version |
Guidance for Food and Drug Administration Field Offices on Regulatory Procedures Manual, Chapter 9, Subchapter,' Import
for Export'. (18SEP02)
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The Guidance Word Version |
Medical Devices;Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Availability. (16SEP02)
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The Guidance |
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. (13SEP02)
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The Draft Guidance Word version |
Discussion of Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health Concern; Notice of Public Meeting. (13SEP02)
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Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and
Animals; Availability. (12SEP02)
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The Draft Guidance |
Withdrawal of Guidances on Estrogen and Estrogen/Progestin-Containing Drug Products. (10SEP02)
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Medical Devices; Draft Guidance; Medical Devices Made With Polyvinylchloride Using the Plasticizer
di-(2-Ethylhexyl)phthalate; Availability.
(06SEP02)
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The Draft Guidance
|
Final Guidance for Industry and Reviewers on How the Center for Veterinary Medicine Intends to Handle Deficient
Submissions Filed During the Investigation of a New Animal Drug; Availability. (05SEP02)
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The Draft Guidance |
Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records; Availability.
(05SEP02)
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The Draft Guidance |
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. (04SEP02)
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The Draft Guidance
|
CVM 200247. 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. (04SEP02)
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The Draft Guidance
|
CVM 200246. 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. (04SEP02)
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The Draft Guidance
|
Draft Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator
Misconduct; Availability. (27AUG02)
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The Draft Guidance |
Draft Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability.
(21AUG02)
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The Draft Guidance |
Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and
Bioavailability; and Labeling Documentation; Availability. (21AUG02)
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The Draft Guidance |
Medical Devices; Class II Special Controls Guidance Document: Dental Sonography Device and the Jaw Tracking Devices; Draft
Guidance for Industry and FDA Reviewers; Availability. (14AUG02)
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The Draft Guidance |
Draft Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In
Vitro Dissolution Testing, Revision; Availability. (07AUG02)
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The Draft Guidance |
Draft Guidance for Industry on Inhalation Drug Products Packaged in Semipermeable Container Closure Systems; Availability.
(26JUL02)
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings
With Sponsors and Applicants for PDUFA Products.
(18JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute
Risoluction; Appeals Above the Division Level.
(18JUL02)
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Medical Devices: Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA; Availability.
(17JUL02)
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The Guidance |
Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy and Dental Mercury Labeling;
Availability. (17JUL02)
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The Draft Guidance |
Draft Revised Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug
Products—General Considerations; Availability.
(11JUL02)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Fast Track Drug Development
Programs--Designation, Development, and Application Review. (08JUL02)
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Supporting Statement
|
Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry,
Manufacturing, and Controls Documentation; Availability. (05JUL02)
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The Guidance |
Withdrawal of 53 Guidances on Individual Product Labeling. (05JUL02)
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Medical Devices; Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry;
Availability. (01JUL02)
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The Guidance |
Guidance for Industry on Providing Regulatory Submissions in Electronic Format- ANDAs; Availability. (27JUN02)
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The Guidance |
Draft Guidance for Industry on Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to
Free Clinics; Availability. (27JUN02)
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The Draft Guidance |
Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidances for Industry on
Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20), and Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus gallus (VICH GL21); Availability. (25JUN02)
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The Guidance Specific Recommendations for Feline (VICH GL20)
The
Guidance Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus gallus (VICH GL21 |
Advertisements for High-Intensity Mercury Vapor Discharge Lamps; Revocation of Compliance Guide 7133.13; Correction.
(25JUN02)
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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.
(25JUN02)
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The Draft Guidance
|
Medical Devices; Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Availability.
(18JUN02)
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The Guidance |
International Conference on Harmonisation; Draft Guidance on Electronic Common Technical Document Specification;
Availability. (14JUN02)
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The Draft Guidance |
International Conference on Harmonisation; Draft Guidance on Q1E Evaluation of Stability Data; Availability. (14JUN02)
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The Draft Guidance |
International Conference on Harmonisation; Draft Guidance on Q1E Evaluation of Stability Data; Availability. (14JUN02)
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The Draft Guidance |
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. (14JUN02)
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The Draft Guidance |
CDER 200239. International Conference on Harmonisation; Stability Data Package for Registration in Climatic Zones III and
IV; Availability. (14JUN02)
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The Draft Guidance |
Guidance for Industry: Channels of Trade Policy for Commodities With Vinclozolin Residues; Availability. (12JUN02)
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The Guidance |
Medical Devices; Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA; Availability. (12JUN02)
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The Draft Guidance |
Pharmacy compounding compliance policy guide. (07JUN02)
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The Guidance
|
Draft Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Availability.
(04JUN02)
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The Draft Guidance |
Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. (23MAY02)
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The Guidance |
Advertisements for High-Intensity Mercury Vapor Discharge Lamps; Revocation of Compliance Policy Guide 7133.13. (21MAY02)
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Guidance for Industry on Preparation of Food Contact Notifications: Administrative; Availability. (21MAY02)
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The Guidance |
Compliance Policy Guidance for FDA Staff and Industry on Blood Donor Classification Statement, Paid or Volunteer Donor;
Availability. (17MAY02)
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The Guidance |
Guidance for Industry on Special Protocol Assessment; Availability. (17MAY02)
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The Guidance
|
ANDAs: Blend Uniformity Analysis; Withdrawal of Draft Guidance. (17MAY02)
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Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability,
Bioequivalence, In Vitro Release and Associated Studies; Withdrawal. (17MAY02)
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Medical Devices; Draft Guidance for Industry and FDA on Class II Special Controls: Root-Form Endosseous Dental Implants
and Abutments; Availability. (14MAY02)
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The Draft Guidance |
Medical Devices; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented
Prosthesis; Availability. (30APR02)
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Medical Devices: Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Final Guidance for
Industry Availability. (29APR02)
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The Guidance
|
Draft Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered
Questionnaires; Availability. (22APR02)
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The Draft Guidance |
Guidance for Industry: Food Contact Substance Notification System; Availability. (11APR02)
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The Guidance--HTML version - Chemistry Recommendations
The Guidance--HTML version - Toxicology Recommendations
|
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. (11APR02)
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The Draft Guidance |
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.
(09APR02)
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The Draft Guidance |
Draft Guidance for Industry on IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products;
Availability. (09APR02)
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The Draft Guidance |
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. (05APR02)
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The Draft Guidance |
Draft Guidance for Industry on Exposure-Response Relationships: Study Design, Data Analysis, and Regulatory Applications;
Availability. (02APR02)
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The Draft Guidance |
Draft Guidance on Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability. (01APR02)
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The Draft Guidance |
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational New Drug
Applications IINDs); Availability.
(29MAR02)
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The Guidance |
Draft Revised Compliance Policy Guide; Male Condom Defects; Availability. (29MAR02)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Fast Track
Drug Development Programs--Designation, Development, and Application Review. (27MAR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. (26MAR02)
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Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Identification of the 20
Most Frequently Consumed Raw Fruits, Vegetables, and Fish. (20MAR02)
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Draft Guidance for Industry on Electronic Records; Electronic Signatures, Time Stamps; Availability. (20MAR02)
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The Draft Guidance |
Draft Guidance for Industry on Developing Drugs to Treat Inhalational Anthrax (Post-Exposure); Availability. (18MAR02)
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The Draft Guidance |
Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions;
Availability. (18MAR02)
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The Guidance |
Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation;"
Availability. (13MAR02)
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The Guidance
|
Guidance for Industry; Implementation of Section 755 of the Agriculture, Rural Development, Food and Drug Administration,
and Related Agencies Appropriations Act of 2002, Pub. L. No. 107-76, § 755 (2001) Regarding Common or Usual Names for Catfish; Availability; Correction. (11MAR02)
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The Guidance
|
Medical Devices; Draft Guidance for Industry and FDA on Premarket Notification Submissions for Medical Sterilization
Packaging Systems in Health Care Facilities; Availability. (07MAR02)
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The Draft Guidance |
Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews.
(06MAR02)
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|
Medical Devices; Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance for
Industry and FDA; Availability. (21FEB02)
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The Draft Guidance
|
Draft Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Availability.
(20FEB02)
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The Draft Guidance |
Draft Guidance for Industry on Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB; Availability.
(20FEB02)
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The Draft Guidance |
Medical Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors;
Draft Guidance for Industry and FDA; Availability. (12FEB02)
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The Draft Guidance |
Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product
Specific Advisory Committees; Availability.
(12FEB02)
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The Draft Guidance |
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. (11FEB02)
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The Draft Guidance |
Draft Guidance for Industry and FDA on Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void
Filler Device; Availability. (07FEB02)
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The Draft Guidance |
Draft Guidance for Industry on Available Therapy; Availability. (07FEB02)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Revised Draft Guidance for Industry
on Developing Medical Imaging Drugs and Biologics. (07FEB02)
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Guidance for Industry; Implementation of Section 755 of the Agriculture, Rural Development, Food and Drug Administration,
and Related Agencies Appropriations Act 2002, Pub. L. No.107-76, Section 755 (2001) Regarding Common or Usual Names for Catfish; Availability. (06FEB02)
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The Guidance
|
CBER 200146. 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. (31JAN02)
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The Draft Guidance |
Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs. (30JAN02)
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|
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products;" Availability. (16JAN02)
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The Guidance
|
Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of
Possible Exposure to Anthrax; Availability.
(14JAN02)
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The Guidance |
Medical Devices: General Principles of Software Validation; Final Guidance for Industry and FDA Staff; Availability.
(11JAN02)
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The Guidance
|
Food Security Guidance; Availability. (09JAN02)
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The Guidance
"Food Producers, Processors, Transporters, and Retailers: Food Security Preventive Measures Guidance"
The Guidance ¥Importers and Filers: Food Security Preventive Measures Guidance" |
Small Entity Compliance Guide: Structure/Function Claims; Availability. (09JAN02)
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The Guidance
|
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Final Guidance for Industry on ''Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23); Availability. (04JAN02)
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The Guidance
|
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal
Products (VICH); Final Guidance on ''Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing'' (VICH GL22); Availability. (04JAN02)
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The Guidance
|
