International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances. (29DEC00)
Click here for txt or pdf
Prepublication display |
Antiviral Drugs Advisory Committee; Notice of Meeting. (27DEC00)
Click here for txt
or
pdf
Prepublication display |
Anti-Infective Drugs Advisory Committee; Notice of Meeting. (27DEC00)
Click here for txt
or
pdf
Prepublication display |
Antiviral Drugs Advisory Committee; Notice of Meeting. (27DEC00)
Click here for txt
or
pdf
Prepublication display |
Arthritis Advisory Committee; Notice of Meeting. (27DEC00)
Click here for txt
or
pdf
Prepublication display |
Transmissible Spongiform Encephalopathies (TSE) Advisory Committee; Notice of Meeting. (27DEC00)
Click here for txt or pdf
Prepublication display |
Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription
Drug Product Labels. (22DEC00)
Click here for
txt or pdf
Prepublication display |
Agency Information Collection Activities; Proposed Collection; Comment Request; Transmittal of Advertising and Promotional
Labeling for Drugs and Biologics for Human Use (21DEC00)
Click here for txt or pdf
Prepublication display |
International Conference on Harmonisation; Guidance on E11 Clinical Investigation of Medicinal Products in the Pediatric
Population; Availability. (15DEC00)
Click here for
txt or pdf
Prepublication display
The Guidance |
Draft Guidance for Industry on Botanical Drug Products; Availability; Reopening of Comment Period. (15DEC00)
Click here for txt or pdf
Prepublication display
Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; Affirmation of Generally Recognized as Safe (GRAS)
Status. (12DEC00)
Click here for txt or pdf
Prepublication display
Supporting Statement |
Draft Guidance for Industry on Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a));
Availability. (04DEC00)
Click here for txt or pdf
Prepublication display
The Guidance |
Digoxin Products for Oral Use; Revocation of Conditions for Marketing. (24NOV00)
Click here for txt
or
pdf
Prepublication display |
Digoxin Products for Oral Use; Reaffirmation of New Drug Status and Conditions for Marketing. (24NOV00)
Click here for
txt or pdf
Prepublication display |
Agency Information Collection Activities; Proposed Collection; Comment Request; OTC Test Sample Collection Systems for
Drugs of Abuse Testing. (16NOV00)
Click here for txt or pdf
Prepublication display |
Medical Devices Draft Guidance on Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket
Notifications; Availability. (14NOV00)
Click here for
txt or pdf
Prepublication display
The Draft Guidance |
Medical Devices Draft Guidance on Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications;
Availability. (14NOV00)
Click here for txt or pdf
Prepublication display
The Draft Guidance |
Draft Guidance for Industry on Cancer Drug and Biological Products--Clinical Data in Marketing Applications; Availability.
(09NOV00)
Click here for txt or pdf
Prepublication display
The Draft Guidance |
Applications for FDA Approval to Market a New Drug; Proposed Revision of Postmarketing Reporting Requirements. (07NOV00)
Click here for txt or pdf
Prepublication display |
Draft Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. (07NOV00)
Click here for
txt or pdf
Prepublication display
The Draft Guidance
|
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Correction. (03NOV00)
Click here for txt
or
pdf
Prepublication display |
Agency Information Collection Activities; Proposed Collection; Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution (02NOV00)
Click here for txt or pdf
Prepublication display |
Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports. (30OCT00)
Click here for txt or pdf
Prepublication display |
Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products_General
Considerations; Availability. (27OCT00)
Click here for
txt
Prepublication display
The Guidance |
Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications;
Availability. (26OCT00)
Click here for txt or pdf
Prepublication display
The Draft Guidance |
Revised Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; Availability. (26OCT00)
Click here for txt or pdf
Prepublication display
The Guidance |
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting. (19OCT00)
Click here for txt
or
pdf
Prepublication display |
Advisory Committee for Pharmaceutical Science; Notice of Meeting. (17OCT00)
Click here for txt
or
pdf
Prepublication display
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 |
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in
Pediatric Patients; Technical Amendment. (06OCT00)
Click here for txt or pdf
Prepublication display |
Agency Information Collection Activities; Proposed Collection; Comment Request; Year 2000 Continuation of National Surveys
of Prescription Drug Information Provided to Patients (06OCT00)
Click here for txt or pdf
Prepublication display |
Clinical Pharmacology During Pregnancy; Public Meeting. (04OCT00)
Click here for txt
or
pdf
Prepublication display |
Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated New Drug Applications. (02OCT00)
Click here for txt or pdf
Prepublication display |
Rami Elsharaiha; Debarment Order. (29SEP00)
Click here for txt
or
pdf
Prepublication document |
Jay Marcus; Debarment Order. (29SEP00)
Click here for txt or pdf
Prepublication document |
Mohammad Uddin; Debarment Order. (29SEP00)
Click here for txt
or
pdf
Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Affirmation of Generally Recognized
as Safe (GRAS) Status. (25SEP00)
Click here for txt or pdf
Prepublication document |
Streamlining the Blood Donor History Questionnaire; Public Workshop. (20SEP00)
Click here for txt
or
pdf
Prepublication document |
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administration
Procedures; Public Hearing. (19SEP00)
Click here for
txt or pdf
Prepublication document |
Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use. (19SEP00)
Click here for txt
or
pdf
Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Sterility Requirements for Aqueous-Based
Drug Products for Oral Inhalation. (19SEP00)
Click here for
txt or pdf
Prepublication document |
Antiviral Drugs Advisory Committee; Notice of Meeting. (15SEP00)
Click here for txt
or
pdf
Prepublication document |
Lilly Research Laboratories et al.; Withdrawal of Approval of 28 New Drug Applications. (13SEP00)
Click here for txt
or
pdf
Prepublication document |
Draft ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious
Disease Indications;'' Availability. (08SEP00)
Click here for
txt or pdf
Prepublication document
The Draft Guidance
|
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)
Click here for txt or pdf
Prepublication document
The Guidance |
Draft Guidance for Industry on Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls
Documentation; Availability. (30AUG00)
Click here for
txt or pdf
Prepublication document
The Draft Guidance
|
Nonprescription Drugs Advisory Committee; Notice of Meeting. (30AUG00)
Click here for txt
or
pdf
Prepublication document |
Joint Meeting of the Nonprescription Drugs Advisory committee and the Gastrointestinal Drugs Advisory Committee; Notice of
Meeting. (30AUG00)
Click here for txt or pdf
Prepublication document |
Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph. (29AUG00)
Click here for
txt or pdf
Prepublication document |
International Conference on Harmonisation; Draft Guidance on M4 Common Technical Document; Availability. (24AUG00)
Click here for txt or pdf
Prepublication document
The Draft Guidance Basic Guidance
The Draft Guidance Efficacy
The Draft Guidance Quality
The Draft Guidance Safety |
Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee With the Pregnancy Labeling
Subcommittee of the Advisory Committee for Reproductive Health Drugs; Notice of Meeting. (22AUG00)
Click here for txt or pdf
Prepublication document |
Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee With the Pregnancy Labeling
Subcommittee of the Advisory Committee for Reproductive Health Drugs; Notice of Meeting. (22AUG00)
Click here for txt or pdf
Prepublication document |
OC 189. Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee; Notice of Meeting. (22AUG00)
Click here for txt or pdf
Prepublication document |
Pregnancy Labeling Subcommittee Advisory Committee for Reproductive Health Drugs; Notice of Meeting. (22AUG00)
Click here for txt or pdf
Prepublication document |
Draft Guidance for Industry on Botanical Drug Products; Availability. (11AUG00)
Click here for txt
or
pdf
Prepublication document
The Draft Guidance
|
Topical Otic Drug Products for Over-the-Counter Human Use; Products for Drying Water-Clogged Ears;Amendment of
Monograph;Lift of Partial Stay of Effective Date. (10AUG00)
Click here for txt or pdf
Prepublication document |
International Conference on Harmonisation; Draft Guidance on Principles for Clinical Evaluation of New Antihypertensive
Drugs; Availability. (09AUG00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
International Conference on Harmonisation; Draft Guidance on Safety Pharmacology Studies for Human Pharmaceuticals;
Availability. (07AUG00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final
Monograph for OTC Antitussive Drug Products.
(01AUG00)
Click here for txt or pdf
Prepublication document |
International Conference on Harmonisation; Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical
Ingredients; Availability. (01AUG00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Revised Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability. (31JUL00)
Click here for txt
or pdf
Prepublication document
The Draft Guidance |
Request for Nominations for Working Groups Under the Nonclinical Studies Subcommittee of the Advisory Committee for
Pharmaceutical Science. (26JUL00)
Click here for txt or pdf
Prepublication document |
International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Substances. (20JUL00)
Click here for txt or pdf
Prepublication document |
International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Products. (19JUL00)
Click here for txt or pdf
Prepublication document |
Court Decisions, ANDA Approvals, and 180-Day Exclusivity. (13JUL00)
Click here for txt
or pdf
Prepublication document |
Draft Guidance for Industry on Combined Oral Contraceptives--Labeling for Healthcare Providers and Patients; Availability.
(10JUL00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy;Drug Efficacy Study Implementation;
Caramiphen Edisylate; Final Actions on Supplemental New Drug Applications. (07JUL00)
Click here for txt or pdf
Prepublication document |
Certain Single-Entity Coronary Vasodilators Containing Isosorbide Dinitrate; Withdrawal of Approval of Abbreviated New
Drug Applications. (07JUL00)
Click here for txt or pdf
Prepublication document |
Draft Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment; Availability.
(28JUN00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Ophthalmic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph. (21JUN00)
Click here for txt
or pdf
Prepublication document |
Determination That Ranitidine Effervescent 75-Milligram Tablet Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness. (21JUN00)
Click here for txt or pdf
Prepublication document |
Determination That Fluoxetine Hydrochloride 20-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness. (21JUN00)
Click here for txt or pdf
Prepublication document |
Determination That Paroxetine Hydrochloride 10-, 20-, 30-, and 4009Milligram Capsules Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness. (21JUN00)
Click here for
txt or pdf
Prepublication document |
Draft Guidance for Industry on Allergic Rhinitis: Clinical Development Programs for Drug Products; Availability. (21JUN00)
Click here for txt or pdf
Prepublication document
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)
Click here for
txt or pdf
Prepublication document
The Draft Guidance |
Over-the-Counter Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates. (20JUN00)
Click here for
txt
or pdf
Prepublication document |
Draft Guidance for Industry on Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis;
Availability. (14JUN00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Rajaram K. Matkari; Conviction Reversal; Final Order Terminating Debarment. (13JUN00)
Click here for txt or pdf
Prepublication document |
Gastrointestinal Drugs Advisory Committee; Notice of Meeting. (13JUN00)
Click here for txt
or pdf
Prepublication document |
Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Extension of Effective Date; Reopening of
Administrative Record. (08JUN00)
Click here for txt or pdf
Prepublication document |
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting. (08JUN00)
Click here for txt
or pdf
Prepublication document |
Arthritis Advisory Committee; Notice of Meeting. (06JUN00)
Click here for txt
or pdf
Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Changes to an Approved NDA or ANDA. (05JUN00)
Click here for txt or pdf |
Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening
Diseases and Conditions. (01JUN00)
Click here for txt or pdf
Prepublication document |
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation. (26MAY00)
Click here for txt
or pdf
Prepublication document |
Psychopharmacological Drugs Advisory Committee; Notice of Meeting. (23MAY00)
Click here for txt
or pdf
Prepublication document |
Draft Guidance for Industry on Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment;
Availability (19MAY00)
Click here for txt or pdf
Prepublication document
The Draft Guidance |
Determination of Regulatory Review Period for Purposes of Patent Extension; Neuro Cybernetic Prosthesis (NCP G6 T2 K)
System; Amendment. (15MAY00)
Click here for txt or pdf
Prepublication document |
The Future of the International Conference on Harmonization of Technical Requirements for the Registration of
Pharmaceuticals for Human Use (ICH); Notice of Public Meeting. (04MAY00)
Click here for txt or pdf
Prepublication document |
Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative
Procedures; Delay of Effective Date; Reopening of Administrative Record. (03MAY00)
Click here for txt or pdf
Prepublication document |
International Drug Scheduling; Convention on Psychotropic Substances; 4-Bromo-2,5-dimethoxyphenethylamine (2C-B);
Gamma-hydroxybutyr |
