Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition; Amendment; Delay of Effective Date.
(27NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; GLEEVEC. (18NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; EVOXAC. (18NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; COLAZAL. (14NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; LOTRONEX. (14NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; ACOVA. (14NOV02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; SOLAGE. (14NOV02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; New Drug and Biological Drug Products;
Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible. (13NOV02)
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Determination That Sodium Tetradecyl Sulfate Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
(07NOV02)
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180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications; Proposed rule; withdrawal (01NOV02)
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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 |
Women's Health Initiative Subcommittee of the Advisory Committee for Reproductive Health Drug; Notice of Cancellation of
Meeting for November 12 and, November 13, 2002.) (01NOV02)
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Solicitation of Public Review and Comment on Research Protocol: A Multicenter, Ramdomized Dose Response Study of the
Safety, Clinical and Immune Response of Dryvax Administered to Children 2 to 5 Years of Age. (31OCT02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized
as Safe Exemption Based on a Generally Recognized as Safe Determination. (31OCT02)
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Antimicrobial Drug Development; Public Workshop. (29OCT02)
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FDA Regulation of Combination Products; Public Hearing. (28OCT02)
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Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on
Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed. ([Pre-Pub] is about 70 pages in length). (24OCT02)
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Agency Information Collection Activities; Announcement of OMB Approval; Postmarketing Adverse Drug Experience
Reporting. (23OCT02)
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Supporting Statement Word Version
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Women's Health Initiative Subcommittee of the Advisory Committee for Reproductive Health Drugs; Notice of Meeting.
(21OCT02)
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Agency Information Collection Activities; Announcement of OMB Approval; Regulations for In Vivo Radiopharmaceuticals Used
for Diagnosis and Monitoring. (18OCT02)
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Supporting Statement |
Determination That Dextroamphetamine Sulfate Tablets, 15 Milligrams, Were Not Withdrawn from Sale for Reasons of Safety or
Effectiveness. (18OCT02)
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Lilly Research Labs et al.; Withdrawal of Approval of 16 New Drug Applications and 30 Abbreviated New Drug Applications.
(10OCT02)
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Agency Information Collection Activities; Announcement of OMB Approval; the Evaluation of Long-Term Antibiotic Drug
Therapy for Persons Involved in Anthrax Remediation. (08OCT02)
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Supporting Statement |
Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use. (04OCT02)
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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 |
Administrative practice and procedure: Ozone-depleting substances use; essential-use determinations. GPO Correction.
(17SEP02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (16SEP02)
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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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Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records; Availability.
(05SEP02)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice; Regulations
for Finished Pharmaceuticals. (27AUG02)
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Supporting Statement |
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the
Tentative Final Monograph, and Related Labeling.
(21AUG02)
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Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition;
Correction. (21AUG02)
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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 |
Nonprescription Drugs Advisory Committee; Notice of Meeting. (20AUG02)
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Agency Emergency Processing under OMB Review; The Evaluation of Long-Term Antibiotic Drug Therapy for Persons Involved in
Anthrax Remediation Activities. (19AUG02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations Requiring Manufacturers
to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. (13AUG02)
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Amendment of Regulations on Aluminum in Large and Small Volume Parenterals Used in Total Prenteral Nutrition. (12AUG02)
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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 |
Determination That Cyanocobalamin Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. (26JUL02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; Definity. (26JUL02)
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Antiviral Drugs Advisory Committee; Notice of Meeting. (25JUL02)
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Food Biotechnology Subcommittee of the Food Advisory Committee; Notice of Meeting. (25JUL02)
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Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (25JUL02)
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Use of Ozone-Depleting Substances; Essential-Use Determinations. (24JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations.
(22JUL02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; CeeOn Model 911A. (17JUL02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; PEG-Intron. (16JUL02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; Protonix. (16JUL02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; Axert. (16JUL02)
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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 |
Human drugs: Unapproved new investigational drug products; export requirements. GPO Correction. (05JUL02)
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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 |
Determination That Piperacillan for Injection USP, 40-Gram Pharmacy Bulk Package, Was Not Withdrawn From Sale for Reasons
of Safety or Effectiveness. (03JUL02)
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Guidance for Industry on Providing Regulatory Submissions in Electronic Format- ANDAs; Availability. (27JUN02)
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The Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final 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. (27JUN02)
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The
Guidance VICH GL15 Effectiveness of Anthelmintics: Specific Recommendations for Equine
The
Guidance VICH GL16 Effectiveness of Anthelmintics: Specific Recommendations for Porcine
The
Guidance VICH GL19 Effectiveness of Anthelmintics: Specific Recommendations for Canine |
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 |
Determination of Regulatory Review Period for Purposes of Patent Extension; BETAXON. (26JUN02)
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Bar Code Label Requirements for Human Drug Products; Notice of Public Meeting; Correction. (26JUN02)
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Digoxin Products for Oral Use; Revocation of Conditions for Marketing. (26JUN02)
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CDER 01185 Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment. (20JUN02)
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Investigational New Drugs: Export Requirements for Unapproved New Drug Products. (19JUN02)
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Bar Code Label Requirements for Human Drug Products; Notice of Public Meeting. (18JUN02)
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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 |
Postmarket Surveillance.
(06JUN02)
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New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy
Studies Are Not Ethical or Feasible.
(31MAY02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Temporary Marketing Permit
Applications. (30MAY02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; ENBREL. (28MAY02)
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Pediatric Subcommittee of Anti-Infective Drugs Advisory Committee; Notice of Meeting. (24MAY02)
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Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. (23MAY02)
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The Guidance |
Determination That Ardeparin Sodium Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
(23MAY02)
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Freedom of Information Summary |
Determination of Regulatory Review Period for Purposes of Patent Extension; COMTAN. (22MAY02)
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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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Agency Information Collection Activities; Announcement of OMB Approval; Format and Content Requirements for
Over-the-Counter (OTC) Drug Product Labeling.
(15MAY02)
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Supporting Statement |
Determination of Regulatory Review Period for Purposes of Patent Extension; ACTOS. (15MAY02)
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Determination That IFEX (Ifosfamide for Injection), 1-Gram and 3-Gram Vials, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness. (14MAY02)
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Pediculicide Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph. (10MAY02)
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Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients concerning stimulant laxative
ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada
fluidextract). (09MAY02)
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Determination That Acetaminophen and Codeine Phosphate Tablets, 500 Milligrams (mg)/15 mg, 500 mg/30 mg, and 500 mg/60 mg,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. (07MAY02)
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Joint Meeting of the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee. (07MAY02)
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Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format (03MAY02)
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Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting. (01MAY02)
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Agency Information Collection Activities; Announcement of OMB Approval; Application for FDA Approval to Market a New Drug.
(30APR02)
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Supporting Statement |
Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics. (24APR02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; MIFEPREX; Extension of Comment Period.
(17APR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (16APR02)
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Risk Management of Prescription Drugs; Public Hearing. (15APR02)
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Drug Information Association and Food and Drug Administration on the Fourth Project Management Workshop: Effective
Agency/Industry Interactions to Expedite Drug Development; Public Workshop. (10APR02)
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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 |
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Amfepramone
(diethylpropion); Amineptine; Buprenorphine; Delta-9-tetrahydrocannabinol (dronabinol); Tramadol. (09APR02)
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates. (05APR02)
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Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Preliminary Draft Proposed Rule.
(01APR02)
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Preliminary Draft Proposed Rule |
Draft Guidance on Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability. (01APR02)
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|
Drug Manufacturing Inspections; Public Workshops. (29MAR02)
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Agency Information Collection Activities; Announcement of OMB Approval; Foreign Establishment Registration and Listing.
(26MAR02)
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Supporting Statement |
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 |
Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph ; Correction. (15MAR02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo
Radiopharmaceuticals Used for Diagnosis and Monitoring. (14MAR02)
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Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews.
(06MAR02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; Diphenylmethane Diisocyanate. (04MAR02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; HECTOROL. (01MAR02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; PAYLEAN. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; NEXIUM. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; EVISTA. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; REMINYL. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; TRAVATAN. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; ABREVA. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; AVELOX. (28FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; RELENZA. (28FEB02)
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Freedom of Information Summary |
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience
Reporting. (25FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; Celexa. (25FEB02)
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Antiviral Drugs Advisory Committee; Notice of Meeting. (25FEB02)
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Draft Guidance for Industry on Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB; Availability.
(20FEB02)
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The Draft Guidance |
Determination That Azathioprine 25-Milligram Tablet Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.
(20FEB02)
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Mylan Pharmaceuticals et al.; Withdrawal of Approval of 34 Abbreviated New Drug Applications. (20FEB02)
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Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative
Procedures; Delay of Effective Date.
(13FEB02)
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Peripheral and Central Nervous System Drugs Advisory Committee Meeting; Cancellation. (12FEB02)
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Aventis Pharmaceuticals et al.; Withdrawal of Approval of 12 New Drug Applications. (11FEB02)
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Agency Information Collection Activities; Announcement of OMB Approval; Assessment of Physician and Patient Attitudes
Toward Direct-to-Consumer Promotion of Prescription Drugs. (08FEB02)
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Supporting Statement |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Financial Disclosure by Clinical
Investigators. (08FEB02)
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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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Determination of Regulatory Review Period for Purpose of Patent Extension; REFACTO. (05FEB02)
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Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs. (01FEB02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; SONATA. (25JAN02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; MIFEPREX. (25JAN02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; KEPPRA. (25JAN02)
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Determination of Regulatory Review Period for Purposes of Patent Extension; T-Scan 2000. (24JAN02)
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Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective
and Not Misbranded. (23JAN02)
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Immunosuppressive Drugs Subcommittee of the Antiviral Drugs Advisory Committee; Notice of Meeting (02JAN02)
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