US FDA DATABASES
Electronic Orange Book
The Online Electronic Orange Book is an online database of approved drug products with therapeutic equivalence evaluations as per US FDA. It provides timely consumer information on generic drugs. It is updated daily as new generic approvals occur. Search facilities for active ingredient, application holder, proprietary name, application number and patent
The Orange Book annual addition, current cumulative supplement, monthly additions and deletions are available at FDA website at http://www.fda.gov/cder/orange/default.htm and at http://www.fda.gov/cder/ob/docs/preface/eclink.htm
Drugs@FDA allows searching official information about FDA approved brand name and generic drugs and therapeutic biological products.
The main uses of Drugs@FDA are:
• finding labels for approved drug products
• finding generic drug products for a brand name drug product
• finding therapeutically equivalent drug products for a brand name or generic drug product
• finding consumer information for drugs approved from 1998 on
• finding all drugs with a specific active ingredient
• viewing the approval history of a drug
Inactive Ingredient Database
The Inactive Ingredients 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. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product.
This site contains lists of Drug Master Files (DMFs) as well as information concerning submission of DMFs.
EAFUS: Food Additive Database
The EAFUS list of substances contains ingredients added directly to food that FDA has either approved as food additives or listed or affirmed as GRAS. Nevertheless, it contains only a partial list of all food ingredients that may in fact be lawfully added to food, because under federal law some ingredients may be added to food under a GRAS determination made independently from the FDA. The list contains many, but not all, of the substances subject to independent GRAS determinations.
EDQM (EUROPEAN DIRECTORATE OF FOR THE QUALITY OF MEDICINES AND HEALTHCARE) DATABASES
Knowledge is a searchable database of information on a given substance or general method of analysis.
European Pharmacopoeia Reference Standards
Search through continuously updated database for information on European Pharmacopoeia reference standards.
ISA WHO International Standards
This database contains information on WHO International Standards for Antibiotics (ISA).
Search Certification database for information on Certificates of Suitability (CEPs) granted by the EDQM.
Database on the legal classification of medicines as regards their supply: conditions and details of prescription status.
CLINICAL TRIALS INFORMATION
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.
US Patent and Patent Application Database
Database with US Patents issued from 1975 until present.
European Patent Database
Search Worldwide, WIPO and European Patents from a single location.
Japanese Patent Abstracts Database
Get English abstracts of Japanese patents.
PATENTSCOPE Database of WIPO
This service provides access to published PCT international applications and to the latest bibliographic data and documents contained in the files of PCT international applications. Due to changes in the PCT Regulations and to the availability of documents in electronic form, the information available is different depending on the date of filing of the international application. This facility allows you to search PCT patent applications and to view the latest information and documents available to the International Bureau.
Friday, April 11, 2008
US FDA DATABASES