2. INTRODUCTION ABOUT CDER DRUG INFORMATION REGULATORY GUIDANCE CDER CALENDER SPECIFIC AUDIENCES CDER ARCHIVES POSSIBLE QUESTIONS REFERENCES

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

4. 1. ABOUT CDER 1.1 Who We Are: 1.1.1 CDER Personnel Directories 1.1.2 Organization charts 1.1.3 CDER Office and Subject Home Page

5. 1.2 What We Do: 1.2.1 CDER Drug Product Applications 1.2.2 CDER Small Business Assistance Program 1.2.3 Small business guide to FDA

6. 1.2 What We Do: 1.2.4 CDER Handbook 1.2.4.1 New Drug Development and Review - IND, NDA … 1.2.4.2 Generic Drug Review -ANDA 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 activities describes the Center's processes and activities

7. 1.2.4.3 Over-the-Counter Drug Review Process Over-the-Counter Drug Products Introduction

8. 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."

9. Goal 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.

10. 1.2.4.3 OTC Drug Review Process

11. 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 Reporting To understand how CDER works to assure the ongoing safety & effectiveness of drug products currently available in the market…

12. Post-Marketing Surveillance (PMS) PMS Information Sources Chart MEDWatch Spontaneous Reporting System Pharmacoepidemiology Contracts/Co-operative Agreements  Goal -- accomplished by reassessing drug risks based on new data learned after the drug is marketed & recommending ways of trying to most appropriately manage that risk.  Done by variety of activities and tools..

13. PMS Information Source Chart

14. 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 FDA's actions that have resulted from adverse event and product problem reporting. Increase healthcare providers' understanding and awareness of drug and device-induced disease. MEDWatch - description of FDA's medical product reporting program - since June 1993.

15. Reporting In to MedWatch How to report Patient Product Description of Event or Problem Reporter Reporting In to MedWatch How to report Patient Product Description of Event or Problem Reporter

16. CDER's 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. Spontaneous Reporting System (SRS)

17. 1.2.4.4 b) Prescription Drug Advertising and Promotional Labeling Part of CDER's 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 CDER's Division of Drug Marketing, Advertising and Communications (DDMAC).

18. 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 FDA’s field investigators and analysts. These professionals are organized under FDA’s Office of Regulatory Affairs (ORA), which has twenty-one district offices and many more resident posts throughout the country.

19. 1.2.4.4 d) Medication Errors prescribing, repackaging, dispensing, administering, or monitoring. CDER’s approach to medication errors : - Prevent medication errors prior to a drug’s approval - After approval, evaluate, monitor, and take appropriate action on reports of medication errors. - Educate and provide feedback to health professionals and - Share information with outside organizations involved in preventing medication errors

20. 1.2.4.4 e) Drug Shortages It is FDA's policy to attempt to prevent or alleviate shortages of medically necessary products. Reporting Drug Shortages External reports on drug shortages are received in CDER through a variety of means. One such means is the Drug Shortage System which is maintained by the Center's Drug Quality Reporting System (DQRS). DQRS is the preferred entry point for consumer reports of drug shortages. Other sources of drug shortage information include FDA's Office of Health Affairs, which is a focal point for drug shortage reports from health professionals.

21. 1.2.4.4 f) Therapeutic Inequivalence Reporting In the past 10 years, FDA's 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.

22. 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 – CDER home page. 1.2.4.5 c) CDER Ombudsman – is the center contact for jurisdictional issues involving drug/device/biological products. 1.2.4.5 d) Videoconferencing

23. 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) Women's Health Issues 1.2.4.6 e) CDER Pediatric Initiatives 1.2.4.6 f) "International Conference on Harmonization"

24. 1.3 What We have Accomplished: 1.3.1 News Along the Pike 1.3.2 CDER 2005 Report to the Nation: Improving Public Health Through Human Drugs. 1.3.3 FDA's Drug Review and Approval TimesFDA's Drug Review and Approval Times 1.3.4 New Drug Approval Reports Status reportsNew Drug Approval Reports of drug approvals by calendar year. 1.3.5 Prescription Drug User Fee Act (PDUFA) Reports to CongressPrescription Drug User Fee Act (PDUFA) Reports to Congress

25. 2. DRUG INFORMATION 2.1 New Prescription Drug Approvals Drugs@FDA Index to Drug-Specific Information -Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.Index to Drug-Specific Information FDA Drug Approvals List- This is a reverse chronological listing of all drugs approved from September 1996 to August 12, 2002.FDA Drug Approvals List New Drugs Approved for Cancer Indications- This is a current listing of new cancer drugs. It is prepared by FDA's Office of Special Health Issues.New Drugs Approved for Cancer Indications

26. 2.2 Prescription Drug Information Approved Drug Products with Therapeutic Equivalence Evaluations/Orange BookApproved 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) DirectoryNational Drug Code (NDC) Directory. 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 DatabaseInactive 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 InformationIndex to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.

27. 2.3 Drug Information Pathfinder Drug Information PathfinderDrug Information Pathfinder-Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics. 2.4 Consumer Drug Information Index to Drug-Specific InformationIndex to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more. Antimicrobial Resistance Page Common Drugs of Abuse: MarijuanaCommon 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 How To Obtain Domperidone Influenza Antiviral Drugs and Related Information Metered-Dose Inhalers (MDIs) 2.5 Over-the-Counter Drug Information

28. 2.6 Drug Safety & Side Effects Index to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.Index to Drug-Specific Information Accutane (isotretinoin): A Letter to Consumers and Health Care Providers Adverse Events Reporting System AERS Electronic Submissions Clozapine Issue Paper FDA Medical Bulletin FDA Medical Bulletin -Important Information for Health Professionals from the U.S. Food and Drug Administration. FDA Statement on the Results of the Women's Health Initiative Labeling Changes Related to Drug Safety Labeling Changes Related to Drug Safety- The summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert. Labeling Review Branch Labeling Review Branch-This organization unit page contains recent labeling up dates. Medication Errors Web Page

29. 2.6 Drug Safety & Side Effects MedWatch Patient Safety 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 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 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 Information

30. 2.7 Drug Preparedness and Bioterrorism Response Drug Preparedness and Bioterrorism ResponseDrug Preparedness and Bioterrorism Response – information on drug therapy and vaccines, plus advice on purchasing and taking medication.

31. 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.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.ClinicalTrials.Gov Cancer Clinical Trials Listing -This is an alphabetical listing of cancer organizations with extensive information about cancer treatments and clinical trials.Cancer Clinical Trials Listing

32. 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 Children Warning Letters

33. 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 FDA's Drug Review and Approval Times

34. 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)AIDS Information 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).Antiretroviral HIV Drug Approvals and Pediatric Labeling Information Botanical Review Team (Botanical Drug Product Development)Botanical Review Team Cancer Drug Approval Endpoints: FDA Project and Meeting Information.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 therapiesFDA Oncology Tools Pediatric Drug Development Pharmaceutical cGMPs: A Risk-Based Approach Postmarketing Study Commitments Process Analytical Technologies (PAT)

35. 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 Resources

36. 4. CDER CALENDER 4.1 Advisory Committee Meetings 4.2 Meetings, Conferences & Workshops 4.3 CDER News

37. 5. SPECIFIC AUDIENCES 5.1 Consumer & Patient Information - General Information (example- Consumer education) 5.2 Consumer & Patient Information - Drug Information (Over-the-Counter Medicines: What’s 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 Audiences

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

39. 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 “CDER Archives” (2 marks) Write a note on Over-the-counter Drug Review Process. (5 marks) Write a note on “Communicating with CDER” and “Other Activities” (5 marks) Write a note on New Drug Development and Review. (8 marks) Write a note on Post Drug Approval Activities. (10 marks) STUDY QUESTIONS: References:- www.fda.gov/cder