Guidances CDER is Planning to Develop

September 24, 2002
BioPharm International Editors

24 SEPTEMBER - CDER has released a list of guidances they plan to develop.

www.fda.gov/cder/guidance/guidance-agenda.htmGuidance Agenda: Guidances CDER is Planning to Develop During Fiscal Year 2003CATEGORY — Advertising* Advertising and Labeling of Treatment IND Protocols* Patient Reported Outcomes* Promotion of Combination Oral Contraceptive ProductsCATEGORY — Biopharmaceutics* Clozapine Tablets – In Vivo Bioequivalence and In Vitro Dissolution TestingCATEGORY — Chemistry* Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA Technology* Drug Products: Chemistry, Manufacturing, and Control Documentation* Drug Substance: Chemistry, Manufacturing, and Control DocumentationCATEGORY — Clinical/Medical* Acne Vulgaris* Analgesics* Clinical Development Programs for MDI and DPI Drug Products – Revision* Clinical Evaluation of Drugs for the Treatment of Acute Coronary Syndrome* Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women – Revision* Clinical Evaluation of Drugs for Neuropathic Pain* Clinical Evaluation of Drugs for the Treatment of Heart Failure* Collection and Use of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products* Development of New Opiate Formulations* Drug-Coated Cardiovascular Stents* Evaluation of New Treatments for Diabetes Mellitus* Gingivitis* Safety Review of Clinical DataCATEGORY — Clinical/Pharmacology* 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 ReviewersCATEGORY — Compliance* Current Good Manufacturing Practices for Compressed Medical Gases – Revision* Maintaining Adequate and Accurate Records During Clinical Investigations* National Drug Code Number and Drug Product Labels* Describing How PET Drug Products May Comply With New CGMP Requirements – Revision* Sterile Drug Products Produced by Aseptic ProcessingCATEGORY — Electronic Submissions* Providing Electronic Submissions to the Division Of Drug Marketing, Advertising, and Communications* Providing Electronic Submissions in Electronic Format: Marketing Applications and Related Submissions* Providing Regulatory Submissions in Electronic Format – Annual Reports for Approved NDAs* Providing Regulatory Submissions in Electronic Format – General Considerations* Providing Regulatory Submissions in Electronic Format: Postmarketing Periodic Adverse Drug Experience Report* Scope and Implementation of Part 11: Archiving* Scope and Implementation of Part 11: Audit Trails* Standards for Clinical Data SubmissionsCATEGORY — Generics* Bioequivalence Studies With Clinical Endpoints for Vaginal Antifungal Drug Products* Chemistry, Manufacturing, and Controls Documentation Unique to Radiopharmaceuticals Submitted in ANDAs* Generic Drug Labeling When Pediatric Labeling Information Has Been Added to the Innovator LabelingCATEGORY – Good Review Practices* General Clinical Review TemplateCATEGORY — IND* Consumer Product Safety Commission – Tamper Resistant Packaging for INDs* Pediatric Safety and Efficacy Data in INDsCATEGORY — Labeling* Content and Format of the Clinical Pharmacology Section* Content and Format of the Warnings and Precautions, Contraindications, and Boxed Warning Sections of Prescription Drug Labeling* Drug Names and Dosage Forms* Pregnancy Labeling Revisions* Submitting Proprietary Names for EvaluationCATEGORY — OTC* Actual Use Trials* Labeling Comprehension Studies for OTC Drug Products* Labeling for Over-The-Counter Human Drug Products* Labeling Over-The-Counter Human Drug Products; Questions and Answers* Time and Extent ApplicationsCATEGORY — PDUFA III* Continuous Marketing Application: Pilot 1 – Discipline Review Letters for Pre-Submitted "Reviewable Units" of NDAs/BLAs* Continuous Marketing Application: Pilot 2 – Frequent Scientific Feedback and Interactions During Drug Development* Good Review Management PrinciplesCATEGORY — Pharmacology/Toxicology* Drug-Induced Vasculitis in Nonclinical Studies* Estimating the Safe Starting Dose for Clinical Trials of Therapeutics in Adult Healthy Volunteers* Immunotoxicology Evaluation of Investigational New Drugs* Nonclinical Safety Evaluation of Pediatric Drug Products* Nonclinical Studies for Development of Pharmaceutical ExcipientsCATEGORY — Procedural* Assessment of Abuse Potential of Drugs* Dispute Resolution Involving Pediatric Labeling* Exocrine Pancreatic Insufficiency Drug Products - New Drug Application Requirements* Process for Contracts and Written Requests Under the Best Pharmaceuticals for Children Act* Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, And Cosmetic Act* Reports on the Status of Postmarketing Studies -- Implementation of Section 130 of FDAMA

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