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Guidance Agenda: (See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details about the Guidance Agenda.) CATEGORY — Advertising · Promotion of Combination Oral Contraceptive Products
CATEGORY — Chemistry · Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA Technology
CATEGORY — Clinical/Medical · Acne Vulgaris · Ankylosing Spondylitis · Antifungal · Choroidal Neovascularization · Clinical Evaluation of Analgesic Drug Products · Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women · Clinical Evaluation of Drugs for Neuropathic Pain · Clinical Evaluation of Drugs for Neuropathy · Clinical Evaluation of Opiate Analgesic Drug Products · Corticosteroid Induced Adrenal Suppression · Development of Drugs for Chronic Obstructive Pulmonary Disease · Developing Antiviral Drugs for the Treatment of Smallpox · Diabetic Retinopathy · Drug-Coated Cardiovascular Stents · Dry Eye · Evaluation of New Treatments for Diabetes Mellitus · Gingivitis · Intraocular Pressure Lowering · Oral Mucositis · Patient Reported Outcomes · Periodontitis · Psoriasis · Safety Review of Clinical Data · Systemic Lupus Erythematosus
CATEGORY — Clinical/Pharmacology· Clinical Lactation Studies - Study Design, Data Analysis, and Recommendations for Labeling · Format and Content of the Clinical Pharmacology Section of Prescription Drug Product Labeling · Immediate Release to Modified Release Dosage Forms · In Vitro Drug Metabolism/Drug Interaction – Guidance for Reviewers · Pharmacokinetics in Pregnancy – Study Design, Data Analysis, and Impact on Dosing and Labeling CATEGORY — Compliance· Maintaining Adequate and Accurate Records During Clinical Investigations · Describing How PET Drug Products May Comply With New CGMP Requirements CATEGORY — Electronic Submissions· Providing Electronic Submissions in Electronic Format: Content of Labeling · Standards for Clinical Data Submissions CATEGORY — Generics· ANDA Suitability Petitions · Bioequivalence Studies with Clinical Endpoints for Vaginal Antifungal Drug Products · Defining the Term Listed Drug with Respect to Amendments and Supplements to ANDAs and 505(b)(2) Applications CATEGORY — Good Review Practices· General Clinical Review Template CATEGORY — IND· Consumer Product Safety Commission – Tamper Resistant Packaging for INDs · End of Phase 2 Meetings · Pediatric Safety and Efficacy Data in INDs CATEGORY — Labeling· Content and Format of the Clinical Pharmacology Section · Content and Format of the Dosage and Administration Section of the Prescription Drug Labeling · Content and Format of the Warnings and Precautions, Contraindications, and Boxed Warning Sections of Prescription Drug Labeling · Drug Names and Dosage Forms · Implementing the New Content and Format Requirements for Prescription Drug Labeling · Pregnancy Labeling Revisions · Submitting Proprietary Names for Evaluation
CATEGORY — OTC · Actual Use Trials · Labeling Comprehension Studies for OTC Drug Products · Labeling for OTC Human Drug Products · Labeling OTC Human Drug Products; Questions and Answers · Time and Extent Applications CATEGORY — PDUFA III· Premarketing Risk Assessment · Risk Management Programs · Risk Assessment of Observational Data: Good Pharmacovigilance and Pharmacoepidemiologic Assessment
CATEGORY — Pharmacology/Toxicology · Drug-Induced Vascular Injury
CATEGORY — Procedural · Assessment of Abuse Potential of Drugs · Dispute Resolution Involving Pediatric Labeling · Exocrine Pancreatic Insufficiency Drug Products – New Drug Application Requirements · How to Comply With the Pediatric Research Equity Act · Process for Contracts and Written Requests Under the Best Pharmaceutical for Children Act · Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic Act
Date created: January 30, 2004 |
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