INTRODUCTION
ABOUT CDER
DRUG INFORMATION
REGULATORY GUIDANCE
CDER CALENDER
SPECIFIC AUDIENCES
CDER ARCHIVES
POSSIBLE QUESTIONS
REFERENCES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION (FDA)
Center for
Biologics
Evaluation &
Research
(CBER)
Center for Drug
Evaluation &
Research
(CDER)
Office of the
Commissioner
Mission…..??
Center for Food
Safety & Applied
Nutrition
(CFSAN)
Center for
Devices &
Radiological
Health
(CDRH)
National Center
for Toxicological
Research
Center for
Veterinary
Medicine
(CVM)
Office of
Regulatory
Affairs
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
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
1.2 What We Do:
1.2.4 CDER Handbook
describes the Center's processes and activities
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
1.2.4.3 Over-the-Counter Drug
Review Process
Over-the-Counter Drug Products
Introduction
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."
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.
1.2.4.3 OTC Drug Review Process
1.2.4.4 Post Drug Approval Activities
To understand how CDER works to assure the ongoing safety &
effectiveness of drug products currently available in the market…
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
Post-Marketing Surveillance (PMS)
 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 ..
PMS Information Sources Chart
MEDWatch
Spontaneous Reporting System
Pharmacoepidemiology
Contracts/Co-operative Agreements
PMS Information Source Chart
MEDWatch - description of FDA's medical product reporting program
- since June 1993.
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.
Reporting In to MedWatch
How to report
Patient
Product
Description of Event
or Problem
Reporter
Spontaneous Reporting System (SRS)
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.
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).
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.
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
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.
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.
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
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"
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 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
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.
• 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 FDA's Office of Special Health Issues.
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. 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.
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.
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
How To Obtain Domperidone
Influenza Antiviral Drugs and Related Information
Metered-Dose Inhalers (MDIs)
2.5 Over-the-Counter Drug Information
2.6 Drug Safety & Side Effects
Index to Drug-Specific Information Provides links to Consumer, Patient, and
Healthcare 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 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- 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-This organization unit page contains recent labeling
up dates.
Medication Errors Web Page
2.6 Drug Safety & Side Effects
MedWatch
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 Information
2.7 Drug Preparedness and Bioterrorism
Response
Drug Preparedness and Bioterrorism Response –
information on drug therapy and vaccines, plus advice
on purchasing and taking medication.
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.
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
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
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)
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
4. CDER CALENDER
4.1 Advisory Committee Meetings
4.2 Meetings, Conferences & Workshops
4.3 CDER News
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
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 Guidance
6.3 Archival Reports & Publications (Annual Adverse
Drug Experience Report )
STUDY QUESTIONS:
• 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)
References:www.fda.gov/cder