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CDER 2007 Update
Internet Resources
CDER Drug and Biologic Approval Reports
You can find reports on drug and biologic approvals at http://www.fda.gov/cder/rdmt/default.htm
Generic Drug Web Site
You can find information about our generic drug program at http://www.fda.gov/cder/ogd/.
OTC Drug Web Site
Information for consumers, manufacturers and health-care professionals about OTC drugs can be found at http://www.fda.gov/cder/offices/otc/default.htm. The Web site includes details about how we regulate OTC drugs. We also include information to help ensure safe use of OTC drugs, including information about pain relievers, reporting adverse drug events, and the use of nonprescription cough and cold medicines in children.
Critical Path
The FDA’s comprehensive Web site on the Critical Path is at http://www.fda.gov/oc/initiatives/criticalpath/. Reports available on the site include those on:
- Generic drugs
- Opportunities initiated during 2006
- The opportunities report
- The list of 76 opportunities
- The original 2004 report and analysis
The site also includes information on meetings and workshops.
Counterterrorism and Emergency Response
We provide the most current information on medical countermeasures and vaccines, plus advice on purchasing and taking medication, at http://www.fda.gov/cder/drugprepare/default.htm.
Public Health Advisories
Links to our Public Health Advisories, early communications, and associated information are at http://www.fda.gov/cder/news/pubpress.htm.
Medication Guides
A list of products with Medication Guides is available at http://www.fda.gov/cder/Offices/ODS/medication_guides.Htm.
Podcasts
Our audio advisories can serve as an alternative to finding this information on our Web site, reading about it in the newspapers or hearing about it from patients. More information is at http://www.fda.gov/cder/drug/podcast/default.htm.
Patient Safety News
Patient Safety News segments are available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm. The subjects of some stories are the emerging safety information about drugs described in our public health advisories and early communications.
Medication Errors
Our comprehensive site on medication errors is at http://www.fda.gov/cder/drug/MedErrors/default.htm.
Adverse Event Reporting
You can learn more about the Adverse Event Reporting System at http://www.fda.gov/cder/aers/default.htm.
MedWatch
- You can find the latest medical product safety information at http://www.fda.gov/medwatch/.
- You can sign up for immediate e-mail or RSS feed notification of MedWatch safety information at http://www.fda.gov/medwatch/elist.htm.
- You can access a video self-learning tutorial FDA MedWatch and Patient Safety at http://www.connectlive/events/fdamedwatch. You will learn more about why your voluntary reporting to MedWatch is critical to our safety surveillance efforts, how we use your reports to make drugs safer and how you can receive new, timely safety information from us that results from your reports.
Drugs@FDA
Drugs@FDA—the most frequently used application on the FDA Web site—has official information about FDA approved brand-name and generic drugs such as:
- Approved and tentatively approved drug products.
- The regulatory history of an approved drug.
- Labels for approved drug products.
- All drugs with a specific active ingredient.
- Generic drug products for a brand-name drug product.
- Therapeutically equivalent drug products for a brand-name or generic drug product.
- Consumer information for drugs approved during the last 10 years.
To use Drugs@FDA, go to our home page http://www.fda.gov/cder and click on “Drugs@FDA.”
User Fees
Our user fee Web site is http://www.fda.gov/cder/pdufa/default.htm and has links to PDUFA:
- Legislation
- Federal Register documents
- Guidances
- Letters
- Performance reports
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CDER 2007 Update Table of Contents
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Date created: July 31, 2008 |
