INTRODUCTIONABOUT CDERDRUG INFORMATIONREGULATORY GUIDANCECDER CALENDERSPECIFIC AUDIENCESCDER ARCHIVESPOSSIBLE QUESTIONSREFERENCES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION (FDA) Center for Center for FoodCenter for Drug Biologics Safety & Applied National Center Evaluation & Evaluation & Nutrition for Toxicological Research Research (CFSAN) Research (CDER) (CBER) Center for Center for Devices & Veterinary Radiological Medicine Health (CVM) (CDRH) Office of the Office of Commissioner Regulatory Affairs

Center for Drug Evaluation and Research

1. ABOUT CDER 1.1 Who We Are: 1.1.1 CDER Personnel Directories 1.1.2 FDA Fact Sheet about CDER: Improving Public Health: Promoting Safe and Effective Drug Use. 1.1.3 FDA Fact Sheet about Drugs 1.1.4 Organization charts 1.1.5 CDER Office and Subject Home PageCenter for Drug Evaluation and Research

1.2 What We Do: 1.2.1Center for Drug Evaluation and Research

1.2 What We Do: 1.2.2 CDER Drug Product Applications 1.2.3 CDER Small Business Assistance ProgramCenter for Drug Evaluation and Research

1.2 What We Do: 1.2.4 CDER Handbook 1.2.4.1 New Drug Development and Review 1.2.4.2 Generic Drug Review 1.2.4.3 Over-the-Counter Drug Review 1.2.4.4 Post Drug Approval Activities. 1.2.4.5 Communicating with CDER 1.2.4.6 Other activitiesCenter for Drug Evaluation and Research

1.2.4.1 The New Drug Development Process: Steps from Test Tube to New Drug Application Review

1.2.4.1 b) IND Review Process

1.2.4.1 b) NDA Review Process

1.2.4.2 Generic Drug Review Process

1.2.4.3 Over-the-Counter Drug Review Process Over-the-Counter Drug Products IntroductionCenter for Drug Evaluation and Research

What is the need for over the counter drug review process There are more than 100,000 OTC drug products marketed, encompassing about 800 significant active ingredients. Most OTC drug products have been marketed for many years, prior to the laws that require proof of safety and effectiveness before marketing. For this reason, FDA has been evaluating the ingredients and labeling of these products as part of "The OTC Drug Review Program."Center for Drug Evaluation and Research

of "The OTC Drug Review Program." The goal of this program is to establish OTC drug monographs for each class of products. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed.Center for Drug Evaluation and Research

1.2.4.3 OTC Drug Review Process

1.2.4.4 Post Drug Approval Activities 1.2.4.4 a) Post-Marketing Surveillance 1.2.4.4 b) Prescription Drug Advertising and Promotional Labeling 1.2.4.4 c) Pharmaceutical Industry Surveillance 1.2.4.4 d) Medication Errors 1.2.4.4 e) Drug Shortages 1.2.4.4 f) Therapeutic Inequivalence ReportingCenter for Drug Evaluation and Research

Post-Marketing Surveillance (PMS) PMS Information Sources Chart MEDWatch Spontaneous Reporting System Pharmacoepidemiology Contracts/Co-operative AgreementsCenter for Drug Evaluation and Research

PMS Information Source ChartCenter for Drug Evaluation and Research

MEDWatch has four goals: Make it easier for healthcare providers to report serious events. Make it clearer to healthcare providers what types of adverse events FDA is interested in receiving. More widely disseminate information on the FDAs actions that have resulted from adverse event and product problem reporting. Increase healthcare providers understanding and awareness of drug and device-induced disease.Center for Drug Evaluation and Research

Spontaneous Reporting System (SRS) CDERs Division of Pharmacovigilance and Epidemiology maintains a Spontaneous Reporting System (SRS) which contains the adverse drug reaction reports from hospitals, health care providers and lay persons that are sent either directly to the Agency (via MEDWatch) or first to the drug manufacturer, and then, by regulation, to the Agency by the manufacturer. In the near future, SRS will be replaced by an expanded system called the Adverse Events Reporting System (AERS), currently under development.Center for Drug Evaluation and Research

1.2.4.4 b) Prescription Drug Advertising and Promotional Labeling Part of CDERs mission is to assure that prescription drug information provided by drug firms is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communications of labeling and promotional information to both health professionals and consumers. This work is accomplished primarily through CDERs Division of Drug Marketing, Advertising and Communications (DDMAC).Center for Drug Evaluation and Research

1.2.4.4 c) Pharmaceutical Industry Surveillance Government oversight of the pharmaceutical industry is usually classified into preapproval and post-approval categories. After the drug is approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the drug is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of drug production and control facilities by FDAs field investigators and analysts. These professionals are organized under FDAs Office of Regulatory Affairs (ORA), which has twenty-one district offices and many more resident posts throughout the country.Center for Drug Evaluation and Research

1.2.4.4 d) Medication Errors prescribing, repackaging, dispensing, administering, or monitoring.Center for Drug Evaluation and Research

1.2.4.4 e) Drug Shortages It is FDAs policy to attempt to prevent or alleviate shortages of medically necessary products. Reporting Drug ShortagesExternal reports on drug shortages are received in CDER through a variety ofmeans. One such means is the Drug Shortage System which is maintained bythe Centers Drug Quality Reporting System (DQRS).DQRS is the preferred entry point for consumer reports of drug shortages.Other sources of drug shortage information include FDAs Office of HealthAffairs, which is a focal point for drug shortage reports from healthprofessionals.Center for Drug Evaluation and Research

1.2.4.4 f) Therapeutic Inequivalence Reporting In the past 10 years, FDAs Center for Drug Evaluation and Research has received more and more reports of drug products that fail to work in patients because the product simply has no effect or is toxic. These problems are usually attributed to switching brands of drugs. As a result, on Sept. 14, 1988, FDA created in CDER the Therapeutic Inequivalence Action Coordinating Committee (TIACC) to identify and evaluate reports of therapeutic failures and toxicity that could indicate that one product is not equivalent to another similar product.Center for Drug Evaluation and Research

1.2.4.5 Communicating with CDER 1.2.4.5 a) Consumer/Industry Inquiries -Division of Communications Management (DCM) 1.2.4.5 b) Regulatory Correspondence 1.2.4.5 c) CDER Ombudsman 1.2.4.5 d) VideoconferencingCenter for Drug Evaluation and Research

1.2.4.6 Other Activities 1.2.4.6 a) Orphan Drugs 1.2.4.6 b) Drug Registration and Listing System 1.2.4.6 c) Environmental Assessments 1.2.4.6 d) Womens Health Issues 1.2.4.6 e) CDER Pediatric Initiatives 1.2.4.6 f) "International Conference on Harmonization"Center for Drug Evaluation and Research

1.2 What We Do: Center for Drug Evaluation and Research Fact Book 1997 - This publication provides an overview of the diversity of activities and responsibilities within the Center. FDA Consumer - Articles with Information About CDER and Our Drug Review Process FDA Consumer Magazine - An archive of FDA Consumer Magazine from 1989-Present. FDA News - Latest Information from the U.S. Food and Drug Administration - Press releases and additional information not found on this CDER home page. From Test Tube to Patient: Improving Health Through Human Drugs (2/2006) Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations. [HTML] or [PDF] (3/12/2003) Human Drug Advisory Committees. Links to meeting transcripts and related information. Managing the Risks from Medical Product Use: Creating a Risk Management Framework (Posted 5/10/1999). Executive Summary . Full Report (164 pages) . Manual of Policies and Procedures (MaPPs) . CDERs official policies and procedures manual. Questions About CDER (4/17/2000). Answers to some commonly asked questions about CDER. Reviewer Diagram Project (6/23/1999). Several approaches to reviewing drug applications Small Business Guide to FDA. About FDAs organization, procedures, policies, and regulations.Center for Drug Evaluation and Research

1.3 What We have Accomplished: 1.3.1 News Along the Pike 1.3.2 CDER 2004 Report to the Nation: Improving Public Health Through Human Drugs. 1.3.3 FDAs Drug Review and Approval Times 1.3.4 New Drug Approval Reports Status reports of drug approvals by calendar year. 1.3.5 Prescription Drug User Fee Act (PDUFA) Reports to Congress 1.3.6 Office of Drug Safety Annual Report 2001Center for Drug Evaluation and Research

1.4 Regulatory Authority Compilation of Laws and Related Statutes Enforced b Federal Food, Drug, and Cosmetic ActCenter for Drug Evaluation and Research

1.5Feedback from Stakeholders Conversation with Stakeholders Report-April 1999Center for Drug Evaluation and Research

1.6 Training New Drug Development in the United StatesCenter for Drug Evaluation and Research

1.7 Employment Opportunities at CDERCenter for Drug Evaluation and Research

1.8 How to Contact Us: Drug Information Questions Ombudsman Policy Questions Web Site FeedbackCenter for Drug Evaluation and Research

2. DRUG INFORMATION 2.1 New Prescription Drug Approvals Drugs@FDA New and Generic Drug Approvals - This is an alphabetical listing of all prescription and over-the-counter drugs approved during 1998 through 2003. It is updated on a daily basis and contains links to labels, approval letters, and reviews. Index to Drug-Specific Information -Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more. FDA Drug Approvals List- This is a reverse chronological listing of all drugs approved from September 1996 to August 12, 2002. New Drugs Approved for Cancer Indications- This is a current listing of new cancer drugs. It is prepared by FDAs Office of Special Health Issues .Center for Drug Evaluation and Research

2.2 Prescription Drug Information Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book . The Orange Book lists all FDA approved prescription drugs, including new and generic drugs. The Orange Book Page includes a searchable Orange Book, as well as a text version, supplements, and downloadable data files. It is updated on a monthly basis. Biological Therapeutic Products Drugs to be Discontinued National Drug Code (NDC) Directory (Updated 4/6/2005). The National Drug Code (NDC) System was originally established as an essential part of an out-of- hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products. Inactive Ingredient Database The database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. Index to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.Center for Drug Evaluation and Research

2.3 Drug Information Pathfinder Drug Information Pathfinder-Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics.Center for Drug Evaluation and Research

2.4 Consumer Drug Information Index to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more. Antimicrobial Resistance Page Common Drugs of Abuse: Marijuana. Information from the National Institute on Drug Abuse. Consumer Education: What You Should Know About Buying and Using Drug Products Beef Insulin: Frequently Asked Questions about Importing Beef Insulin for Personal Use Drug Shortages Generic Drugs: Questions and Answers How To Obtain Domperidone Influenza Antiviral Drugs and Related Information Metered-Dose Inhalers (MDIs)Center for Drug Evaluation and Research

2.5 Over-the-Counter Drug Information Over-the-Counter Drug Page- Information for consumers and industry about non-prescription drugs.Center for Drug Evaluation and Research

2.6 Drug Safety & Side Effects Index to Drug-Specific Information Provides links to Consumer, Patient, andHealthcare Professional Sheets, and more. Accutane (isotretinoin): A Letter to Consumers and Health Care Providers Adverse Events Reporting System AERS Electronic Submissions Clozapine Issue Paper FDA Medical Bulletin -Important Information for Health Professionals fromthe U.S. Food and Drug Administration. FDA Statement on the Results of the Womens Health Initiative Labeling Changes Related to Drug Safety- The summaries include only thosesafety-related sections that have been modified, and therefore do not contain allthe information needed for safe and effective prescribing. Contact themanufacturer for the complete labeling/package insert. Labeling Review Branch-This organization unit page contains recent labelingupdates. Medication Errors Web PageCenter for Drug Evaluation and Research

2.6 Drug Safety & Side Effects MedWatch - The web site for the FDA Medical Products Reporting Program. Miconazole Vaginal Cream and Suppositories Safety Information -FDA updates safety information for Miconazole vaginal cream and suppositories. FDA advises women who take the prescription blood thinner warfarin to consult their doctor or pharmacist for advice before using over-the-counter miconazole vaginal products. Using the two products together could cause bleeding or bruising. Patient Safety- Final Summary of Food and Drug Administration (FDA) Action Items - Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact Preventable Adverse Drug Reactions: A Focus on Drug Interactions Protease Inhibitors Backgrounder -Protease inhibitors are members of a class of antiretrovirals that are generally considered to be the most potent therapeutic agents for HIV to date. In order for these drugs to be effective and to minimize the risk of resistance, it is important that these drugs are prescribed and taken in accordance with the products approved labeling. Reporting Adverse Reactions and Other Problems with Products Regulated by FDA- Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration any adverse reactions or other problems with products the agency regulates. Safety of Sodium Phosphates Oral Solution Visicol: Science Backgrounder: Seizure Associated with the Use of Visicol for Colonoscopy - Additional InformationCenter for Drug Evaluation and Research

2.7 Drug Preparedness and Bioterrorism Response Drug Preparedness and Bioterrorism ResponseCenter for Drug Evaluation and Research

2.8 Clinical Trials Information Information for Clinical Investigators Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999. ClinicalTrials.Gov - This source provides patients, families and members of the public easy access to information about the location of clinical trials, their design and purpose, criteria for participation, and, in many cases, further information about the disease and treatment under study. Cancer Clinical Trials Listing -This is an alphabetical listing of cancer organizations with extensive information about cancer treatments and clinical trials.Center for Drug Evaluation and Research

2.9 Public Health Alerts & Warning Letters Public Health Advisories, 1997 to Present Alcohol Warnings for Pain Relievers and Fever Reducers Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in ChildrenCenter for Drug Evaluation and Research

Warning Letter IndexCompany Date Issuing Subject File ResponseName Warning Office Posted Letter IssuedPfizer Inc. 4/13/05 CDER Labeling/Prom PDF/HTML NO otional Claims False & Misleading/Mis brandedRanbaxy 10/11/02 CDER Certain Drugs PDF/HTML NOPharmaceu Accord Newticals Inc. Drug Status through Rulemaking Procedures/Gua ifenesin

2.10 Reports & Publications CDER Guide to Median Approval Time Statistics Drug Master Files Drug Registration and Listing System Instruction Booklet Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 FDA Consumer Special Issue - From Test Tube to Patient FDAs Drug Review and Approval TimesCenter for Drug Evaluation and Research

2.11 Special Projects & Programs AIDS Information- Offering the latest federally approved information on research, clinical trials, and treatment for patients and health care providers. (External Site) Analgesia and Anti-inflammatory Drug Information Antiretroviral HIV Drug Approvals and Pediatric Labeling Information- This chart lists the drug name, company, adult approval date, and pediatric approval date (if appropriate). Botanical Review Team (Botanical Drug Product Development) Cancer Drug Approval Endpoints: FDA Project and Meeting Information. FDA Oncology Tools. Oncology Tools contains a variety of information related to cancer and approved cancer drug therapies Pediatric Drug Development Pharmaceutical cGMPs: A Risk-Based Approach Postmarketing Study Commitments Process Analytical Technologies (PAT)Center for Drug Evaluation and Research

3. REGULATORY GUIDANCES 3.1 Regulatory & Scientific Guidances 3.2 Specific Regulatory Initiatives 3.3 Legislation 3.4 Submitting Applications for New Drug Products 3.5 International Activities 3.6 CDER Policies & Procedures 3.7 Compliance Activities 3.8 Freedom of Information Act 3.9 Useful ResourcesCenter for Drug Evaluation and Research

4. CDER CALENDER 4.1 Advisory Committee Meetings 4.2 Meetings, Conferences & Workshops 4.3 CDER News (CDERs small business workshop in Kansas City)Center for Drug Evaluation and Research

5. SPECIFIC AUDIENCES 5.1 Consumer & Patient Information - General Information (example- Consumer education) 5.2 Consumer & Patient Information - Drug Information (Over-the-Counter Medicines: Whats right for you) 5.3 Consumer & Patient Information - Adverse Reactions & Warnings 5.4 Freedom of Information 5.5 International Activities 5.6 Pediatrics 5.7 Small Businesses 5.8 Spanish Speaking AudiencesCenter for Drug Evaluation and Research

6. CDER ARCHIVES Official records, older publications and superseded but still useful information. This classification is currently under development and is not comprehensive 6.1 Drug Information Approved Prior to 1998 6.2 Superseded Guidances 6.3 Archival Reports & Publications (Annual Adverse Drug Experience Report )Center for Drug Evaluation and Research

www.fda.gov/cderwww.accessdata.fda.gov/scripts/wlcfm/issuer.cfm?ISSUER=Center%20for%20Drug%20Evaluation%20and%20Research

What is the goal of OTC Drug Review Program? (2 marks)What is included in Drug Information? (2 marks)What is included in Specific Audiences and CDERArchives (2 marks)Write a note on Over-the-counter Drug Review Process.(5 marks)Write a note on Communicating with CDER and OtherActivities (5 marks)

Write a note on New Drug Development and Review.(8 marks)Write a note on Post Drug Approval Activities. (10 marks)