CDER Index M-S

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Management, Risk -- see Risk Management

Manuals

• CDER Data Standards Manual
• CDER Manual of Policies and Procedures (MaPP)

Medical Bulletin

Medical Gases, Compressed

Medical Imaging and Drug Development

Medication Errors

Medication Guides

MedWatch

Meetings

• CDER Sponsored Workshops and Meetings
• Conference, Meeting, and Workshop Presentations by CDER Staff
• FDA Advisory Committee Calendar
• Upcoming FDA Meetings

Metered-Dose Inhalers

Modernization Act of 1997: CDER-Related Documents

My Medicines

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Natural Disasters

National Drug Code Directory

• Database

• Text Files

New Drugs

• CDER Drug and Biologic Approval Reports
• FDA IND, NDA, ANDA, or Drug Master File Binders
• Generic Drug Review Process
• New Drug Development and Review Process
• Office of Drug Evaluation IV: Pre-Investigational New Drug Consultation Program

News Along the Pike - CDER Newsletter

News Releases

• FDA News Releases
• Public Health Advisories

Nonprescription Products -- see Over-the-Counter (OTC) Drugs

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Offices and Divisions

Older Persons -- see Seniors

Ombudsman

• Ombudsman - CDER
• Ombudsman - FDA

Oncology Tools

Office of Oncology Drug Products Web Wite

Organizational Information

• CDER Handbook
• CDER Key Officials
• CDER Manual of Policies and Procedures (MaPP)
• CDER Offices and Divisions
• CDER Organization Charts and Information Directories
• CDER Reference Guide
• FDA Organization
• HHS Employee Phone Directory

Orphan Products

• Office of Orphan Drug Products Development

Over-the-Counter (OTC) Drugs

• Consumer Education: Over-the-Counter Medicine
• Medicines in My Home
• Office of Nonprescription Products

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Pancreatic Insufficiency Drug Products

Patents

• Patent Term Extension & New Patents Docket Number *95S-0117

Patient Labeling and Risk Communication (includes Medication Guides)

Patients

PDUFA -- see Prescription Drug User Fee Act

Pediatrics

• Drugs and Biological Products in Pediatric Patients
• Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in Children
• Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
• Pediatric Drug Development
• Pediatric Drug Labeling
• Pediatric Drug Studies: Protecting Pint-Sized Patients
• Pediatric use of Adult Drugs
• Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patientsf
• New Drugs and Biological Products in Pediatric Patients
• Tobacco and Children

Petitions -- see Dockets

Pharmaceutical cGMPs: A Risk-Based Approach

Pharmacoepidemiology and Statistical Science, Office of

Pharmacogenomics -- see Genomics

Pharmacology and Toxicology Guidances

Pharmacy Compounding

Pharmacy Student Experiential Program

Phase IV Commitments -- see Postmarketing Study Commitments

Phone Directory, HHS

Planning, Office of

Postmarketing Study Commitments

Prescription Drug User Fee Act (PDUFA)

• Prescription Drug User Fee Act: Reports and Plans
• Prescription Drug User Fee Act: Related Documents
• Prescription Drug User Fee Act Reauthorization

Prescription Drug Advertising

Presentations, CDER

Policies and Procedures (MaPPs)

Post-Marketing Surveillance and Epidemiology

Process Analytical Technologies (PAT) Initiative

Privacy Statement and Other Information About FDA's Web Site

Problems with FDA-Regulated Products

Product Alerts and Warnings

Product Approvals

Proposed Regulations for Public Comment

Public Affairs

• Public Affairs Specialists Regional Locations
• FDA Public/Private Partnership Program
• Freedom of Information Act (FOIA) Electronic Reading Room
• Public Calendar (information on FDA meetings)

Public Health Alerts & Warning Letters

Publications

• Drug Safety Newsletter
• FDA Consumer Magazine
  • Homepage
  • Articles About CDER
• Human Drug CGMP Notes
• Medical Bulletin
• News Along the Pike (CDER newsletter)
• Publicaciones en Español

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Quick Index to General Subjects Related to Drug Regulation -- see CDER Reference Guide

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Radioactive Drug Research Committee (RDRC) Program

Recalls, Market Withdrawals and Safety Alerts

Regulations

• Administrative Proceedings and Rule-making Documents
• Code of Federal Regulation (CFR) Title 21 (revised April 1, 2005)
• Electronic Records; Electronic Signatures (21 CFR Part 11)
• Enforcement of Adverse Drug Experience Reporting Regulations
• Federal Register
  • FDA Federal Register (FR) Documents
  • GPO Access
• Office of Regulatory Affairs
• Proposed Regulations
• Regulations Pending
• Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

Regulatory Affairs, Office of

Regulatory Authorities, International

Regulatory and Scientific Issues Related to Developing Follow-On Protein Products

Reinvention Initiatives

Reporting Adverse Reactions and Other Problems with Products

Reports

• CDER Report to the Nation: Improving Public Health Through Human Drugs, 2005: [HTML | [PDF]
  • Earlier reports are located in CDER Archives
• CDER Guide to Median Approval Time Statistics (1/31/2003)
• Conversation with Stakeholders Report-April 1999 (5/19/99)
• FDA Enforcement Reports
• The Future of Drug Safety — Promoting and Protecting the Health of the Public. FDA's Response to the Institute of Medicine's 2006 Report (1/20/2007)
• Managing the Risks from Medical Product Use: Creating a Risk Management Framework
• New Drug Approval Reports
• Prescription Drug User Fee Act Reports
• Risk Management – Executive Summary

Research Fact Book 1997

Reviewer Diagrams

Risk Management

• Be An Active Member of Your Health Care Team
• CDER/CBER Risk Management Public Workshop
• Managing the Risks From Medical Product Use: Creating a Risk Management Framework
  • Executive Summary
  • Full Report
• Patient Labeling and Risk Communication (includes Medication Guides)

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

SAS Drug Formulation Stability Program

Seniors

• FDA Information for Seniors

Shortages, Drugs

Small Business

• Small Business Assistance Program
• Small Business Guide to FDA

Spanish Language Materials

Stakeholders

Statistics, see Pharmacoepidemiology and Statistical Science, Office of

Substance Abuse Treatment Facility Locator

Surveillance, Post-Marketing

Surveillance, Pharmaceutical Industry

Suitability Petitions

Sunscreen Citizen Petition Response – Final Rule

Synthetic Generic Conjugated Estrogens

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Date created: January 31, 2007, Last updated: October 24, 2007

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