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CDER report
This area has information for consumers and industry about generic drug products. Check this area for updates, changes, and announcements.
CDER Document: 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
Licensing, quality inspection and enforcement.
This newly approved or tenatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed.
Arlington, Virginia based independent US government agency responsible for promoting science and engineering through programs that invest over $3.3 billion per year in almost 20,000 research and education projects in science and engineering.
Database of legislation regarding disease control, publications, health topics, news releases.
Approved Drug Products with Therapeutic Equivalence Evaluations: searchable by active ingredients, or by applicant holder
Developed to communicate guidance to FDA field offices. The purpose of an Import Alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel thus providing for more uniform and effective import cov.
Consensus Development Program
Contains all inactive ingredients present in approved drug products or conditionally approved drug products currently marketed for human use.
The Congressional mandate establishing the NCCAM stated that the Center's purpose is to 'facilitate the evaluation of alternative medical treatment modalities' to determine their effectiveness
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
A federal government department, encourages the health of Canadians through promotion and prevention activities, and supports the health system through research funding and the support of provincial/territorial health systems.
Links to maps, markers, publications, and related information.
FDA document in PDF format
Risk of Drug Interactions with St. John's Wort and Indinavir and Other Drugs
CDER document on cancer therapeutics
Official site of the United Nations' international organization working for the highest possible level of health, defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.
Formerly the Agency for Health Care Policy and Research, this agency provides practical health care information, research findings, and data to help consumers, health providers, health insurers, researchers, and policymakers make informed decisi.
Online pharmacy investigation summary.
MedWatch, the FDA Medical Products Reporting Program, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the.
Office of Generic Drugs, Division of Labeling and Program. The purpose of this page is to provide information on recently approved labeling changes for Reference Listed Drug (RLD) products.
U.S. Food and Drug Administration (FDA)homepage
The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies
A federal technology agency that works with industry to develop and apply technology, measurements, and standards.
Reports of adverse reactions categorized by product type, health alerts, and recalls
CDER: The following dates have been set aside by CDER advisory committees for possible future meetings. The subject matter and location of the meetings to be published in the Federal Register in the month prior to the meeting date
Prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest
A division of FDA, site contains drug information, regulatory guidance, CDER archives and calendar.
A service of the Office on Women’s Health in the Department of Health and Human Services. The NWHIC provides a gateway to the vast array of Federal and other women’s health information resources.
An Operating Division (OPDIV) within the Department of Health and Human Services (HHS). Our mission is to provide qualitative and responsive 'support services' on a cost-effective, competitive, 'service-for-fee' basis to HHS components and othe.
The report is published by the World Health Organization
The World Medical Association (WMA) is an international organization representing physicians
Prepared By Division of Data Management and Services Office of Information Technology Center for Drug Evaluation and Research, FDA
This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff. Additional guidance documents, when available in draft or final form, will be added to this page.
Website provides cancer information, resources for scientists, information about partnerships and NCI, recent news and links to its divisions.
CDER Report: Calendar Years 1986-1999 (Updated 2/15/2000)
CDER Document
This area includes meetings and events that are related to CDER's mission
Names of all investigators that the FDA has at one time disqualified, restricted, or required assurances in their use of investigational products.
An agency of the U.S. Department of Health and Human Services, the NIH is the Federal focal point for health research, conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical school.
NCHS is the principal vital and health statistics agency of the US government. A comprehensive resource with links to various surveys, tabulated state data, and more.
Information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational dr.
Regulatory science, publicatinons, department's activities, product information.
Website contains index and searchable database of publications
A national resource for molecular biology information, NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information.
The European system for the authorisation of medicinal products for human and veterinary use is designed to promote both public health and the free circulation of pharmaceuticals
National Library of Medicine, searchable database
The following is a list of Petitions filed, where the Agency determines the suitability or unsuitability of the product.
CDER Document: additions/deletions for prescription drug product list.
Health and health-related statistical information from the WHO Global Programme on Evidence for Health Policy
To protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.
Office of Generic Drugs Phone Directory
The United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The department contains over 300 programs, and the sit.
Service by CDER's Division of Data Management and Services. The Drug approvals on this list are verified and published as they become available and at any given time may not contain all FDA drug approvals.
Regulates the manufacture and distribution of food additives and drugs that will be given to animals
AHRQ, part of the U.S. Department of Health and Human Services, is the lead agency charged with supporting research designed to improve the quality of health care, reduce its cost, and broaden access to essential services.
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