International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances. (29DEC00)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry; Changes to an
Approved NDA or ANDA. (21DEC00)
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Draft ``Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis;''
Availability. (20DEC00)
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Draft Guidance |
Draft Guidance for Industry on Labeling OTC Human Drug Products-Submitting Requests for Exemptions and Deferrals;
Availability. (19DEC00)
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Draft Guidance |
Guidance for Industry on Labeling Over-the-Counter Human Drug Products Using a Column Format; Availabiliy. (19DEC00)
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The Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (VICH GL22); Availability; Request for Comments. (19DEC00)
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Draft Guidance
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Safety Studies for Veterinary Drug Residues in Human Food: Genotoxicity Studies (VICH GL23); Availability; Request for Comments. (18DEC00)
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Draft Guidance
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) (VICH GL24); Availability; Request of Comments. (18DEC00)
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Draft Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidances for Industry on Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20) and Effectiveness of Anthelmintics: Specific Recommendations for Poultry (VICH GL21); Availability;
Request for Comments. (18DEC00)
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Draft Guidance VICH GL20 Recommendations for Feline
Draft Guidance VICH GL21 Recommendations for Poultry |
International Conference on Harmonisation; Guidance on E11 Clinical Investigation of Medicinal Products in the Pediatric
Population; Availability. (15DEC00)
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The Guidance |
Draft Guidance for Industry on Botanical Drug Products; Availability; Reopening of Comment Period. (15DEC00)
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Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry on How to Use E-Mail to
Submit Information to the Center for Veterinary Medicine. (07DEC00)
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Guidance for Industry and for FDA Employees on Import Alert G6 T1# K660966, Detention Without Physical Examination of
Active Pharmaceutical Ingredients That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet the Requirements for the Labeling Exemptions in 21 CFR 201.122; Availability. (04DEC00)
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Draft Guidance for Industry on Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a));
Availability. (04DEC00)
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The Guidance |
Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S.
cerevisiae) Antibody (ASCA) Premarket Notifications; Availability. (22NOV00)
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The Guidance |
Guidance Documents for Premarket Notification (510(k)) Submissions for Indwelling Blood Gas Analyzers; Availability.
(22NOV00)
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The Guidance |
Reports and guidance documents; availability, etc.: Carcinogenicity study protocol submissions; correction. (21NOV00)
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Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol;
Availability. (20NOV00)
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The Guidance |
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts; Availability.
(20NOV00)
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The Guidance |
Draft Guidance for Industry on Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary
Processing of Fish and Fishery Products; Availability. (14NOV00)
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Medical Devices Draft Guidance on Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket
Notifications; Availability. (14NOV00)
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The Draft Guidance |
Medical Devices Draft Guidance on Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications;
Availability. (14NOV00)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry on
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank. (09NOV00)
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Draft Guidance for Industry on Cancer Drug and Biological Products--Clinical Data in Marketing Applications; Availability.
(09NOV00)
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The Draft Guidance |
Draft Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. (07NOV00)
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Final Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval; Availability.
(07NOV00)
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The Guidance |
Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products_General
Considerations; Availability. (27OCT00)
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The Guidance |
Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications;
Availability. (26OCT00)
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The Draft Guidance |
Revised Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; Availability. (26OCT00)
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The Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidances for Industry on ``Effectiveness of Anthelmintics: Specific Recommendations for Equine'' (VICH GL15), ``Effectiveness of Anthelmintics: Specific Recommendations for Porcine'' (VICH GL16), and
``Effectiveness of Anthelmintics: Specific Recommendations for Canine'' (VICH GL19); Availability; Request for Comments. (19OCT00)
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Draft Guidance Specific Recommendations for Equine VICH GL15
Draft Guidance Specific Recommendations for Porcine VICH GL16
Draft Guidance Specific Recommendations for Canine VICH GL19 |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Public Health Service (PHS)
Guideline on Infectious Disease Issues in Xenotransplantation. (18OCT00)
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Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based
Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors; Availability. (18OCT00)
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The Guidance |
Advisory Committee for Pharmaceutical Science; Notice of Meeting. (17OCT00)
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Guidance for Industry,
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Draft Guidance for Industry,
BA and BE Studies for Orally Administered Drug Products-General Considerations
Guidance for Industry, Average, Population, and Individual Approaches to Establishing Bioequivalence |
Agency Information Collection Activities; Announcement of OMB Approval; Submitting and Reviewing Complete Responses to
Clinical Holds; Guidance for Industry. (03OCT00)
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Supporting Statement |
Mutual Recognition Agreement, Medical Device Annex; Confidence Building Activities: Availability of Draft Guidances.
(03OCT00)
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The Draft Guidance |
Draft Guidance for Infant/Child Apnea Monitor 510(k) Submissions; Availability. (22SEP00)
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The Draft Guidance |
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit Information to the Center for Veterinary Medicine. (21SEP00)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Intent to Slaughter for Human Food Purposes. (21SEP00)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter. (21SEP00)
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Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Intent to Slaughter for Human Food Purposes. (21SEP00)
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Administrative Practices and Procedures; Good Guidance Practices. (19SEP00)
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Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document 1B4; Availability. (13SEP00)
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The Draft Guidance
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Draft ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious
Disease Indications;'' Availability. (08SEP00)
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The Draft Guidance
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Draft Guidance for Industry; Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord
Stimulators for Pain Relief; Availability. (06SEP00)
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The Draft Guidance
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Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral
Dosage Forms Based on a Biopharmaceutics Classification System; Availability. (31AUG00)
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The Guidance |
Draft Guidance for Industry on Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls
Documentation; Availability. (30AUG00)
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The Draft Guidance
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International Conference on Harmonisation; Draft Guidance on M4 Common Technical Document; Availability. (24AUG00)
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The Draft Guidance Basic Guidance
The Draft Guidance Efficacy
The Draft Guidance Quality
The Draft Guidance Safety |
Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability. (14AUG00)
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The Draft Guidance |
Guidance for Industry on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals;
Availability. (14AUG00)
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The Guidance |
Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms; Availability. (14AUG00)
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The Draft Guidance |
Draft Guidance for Industry on Botanical Drug Products; Availability. (11AUG00)
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The Draft Guidance
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Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for
the Fragmentation of Kidney and Ureteral Calculi: Availability. (09AUG00)
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The Guidance
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Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act
of 1997; Availability. (09AUG00)
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The Guidance
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International Conference on Harmonisation; Draft Guidance on Principles for Clinical Evaluation of New Antihypertensive
Drugs; Availability. (09AUG00)
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The Draft Guidance |
International Conference on Harmonisation; Draft Guidance on Safety Pharmacology Studies for Human Pharmaceuticals;
Availability. (07AUG00)
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The Draft Guidance |
Obstetrical and Gynecological Devices; Classification of the Clitoral Engorgement Device. (02AUG00)
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International Conference on Harmonisation; Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical
Ingredients; Availability. (01AUG00)
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The Draft Guidance |
Draft Guidance for Industry on Refractive Implants: Investigational Device Exemptions (IDE's) and Premarket Approval
Applications (PMA's); Availability. (01AUG00)
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The Draft Guidance |
Revised Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability. (31JUL00)
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The Draft Guidance |
Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient
Examination Gloves; Availability. (26JUL00)
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The Draft Guidance |
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration. (21JUL00)
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International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Substances. (20JUL00)
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International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Products. (19JUL00)
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Blood Standards; Pilot Program for Licensing and Draft Guidance for Industry: CBER Pilot Licensing Program for
Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier;'' Availability. (18JUL00)
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The Draft Guidance |
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Availability. (18JUL00)
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The Guidance |
Guidance for Industry and FDA Reviewers on Medical Device Use--Safety: Incorporating Human Factors Engineering into Risk
Management; Availability.18JUL00)
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The Guidance |
Medical Devices; Draft Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the
FDA Modernization Act of 1997; Availability. (18JUL00)
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Draft Guidance for Industry: Food-Contact Substance Notification System; Availability. (13JUL00)
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The Draft Guidance |
Draft Guidance for Industry on Combined Oral Contraceptives--Labeling for Healthcare Providers and Patients; Availability.
(10JUL00)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Submitting
and Reviewing Complete Responses to Clinical Holds. (05JUL00)
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Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for
Immediate Slaughter; Availability. (29JUN00)
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The Draft Guidance |
Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes;
Availability. (29JUN00)
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The Draft Guidance |
Draft Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New
Animal Drug Evaluation; Availability. (29JUN00)
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The Draft Guidance |
Draft Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine;
Availability. (29JUN00)
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The Draft Guidance |
Final Guidance: Importation of Pasteurized Milk Ordinance (PMO) Defined Dairy Products (M-I-00-4); Availability. (28JUN00)
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The Guidance |
Draft Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment; Availability.
(28JUN00)
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The Draft Guidance |
Draft Guidance for Industry on Allergic Rhinitis: Clinical Development Programs for Drug Products; Availability. (21JUN00)
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The Draft Guidance |
Draft Guidance for Industry on the Content and Format of the Adverse Reactions Section of Labeling for Human Prescription
Drugs and Biologics; Availability. (21JUN00)
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The Draft Guidance< |
