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Topics on this Page:

 

Animal & Veterinary Health 
CVM Updates
Updates and news releases from FDA’s Center for Veterinary Medicine (CVM)

CVM What’s New
New Items posted to FDA ’s Center for Veterinary Medicine (CVM) website

 

Biologics 
Blood Guidances
Guidance documents related to blood products and blood establishments, links to information about blood publications and FDA’s Blood Action Plan

Blood Products Advisory Committee
Information on current and past meetings of the Blood Products Advisory Committee

Cellular, Tissue and Gene Therapies Advisory Committee
Information on current and past meetings of the Cellular, Tissue and Gene Therapies Advisory Committee (Formerly Biological Response Modifiers Advisory Committee)

FDA Patient Safety News (video)
TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines and diagnostic products

MedSun
Adverse event reporting program for the clinical community to identify, understand, and solve problems with the use of medical devices

Tissue Related Documents
Guidance, rules and related documents on Human Cells, Tissues, and Cellular and Tissue Based-Products

What’s New at CBER
New Items posted to the Center for Biologics Evaluation and Research website

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Color Additives 
Color Additive News 
Color Additives announcements and recent additions to the color additives web site.

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Consumer Health Information 
FDA Consumer Health Information
Timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including human drugs, drugs and feed for animals, medical devices, vaccines, blood, food, dietary supplements, and cosmetics.

Patient Network News
A twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

FDA Consumer Education about Medicine
Consumer education on making the best medicine choices, buying safely, and using medicine in ways that increase its safety and effectiveness

Medicines in My Home
An interactive and educational program for adolescents and adults about the safe and effective use of over-the-counter medicines

Public Health Focus : Illinois
The Public Health Focus: Illinois listserv provides consumers and their families new and ongoing safety information on food, nutrition, drugs, medical devices, cosmetics, tobacco, vaccines, and biologics. It also provides information about local FDA events and presentations.

Minority Health
The Office of Minority Health Newsletter is a quarterly newsletter offering practitioners and advocates valuable information on the latest in minority-focused food and drug safety, cultural competency, and ways you can inform future directions in research.

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Cosmetics 
FDA/CFSAN Cosmetics News
FDA/CFSAN Cosmetics Announcements and Recent Additions to the Cosmetics Web Site

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Dietary Supplements 
Dietary Supplements and Food Labeling
Labeling requirements for foods under the Federal Food Drug and Cosmetic Act and its amendments

FDA Patient Safety News (video)
TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines and diagnostic products

MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories

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Diseases and Conditions 
HIV/AIDS
The HIV/AIDS listserve gives patients, industry, academia, other government agencies, and other interested parties one source for FDA HIV/AIDS related information on a variety of topics, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment.

Hepatitis A and B
Updates on safety and regulatory issues related to Hepatitis A and B, including product approvals, significant drug labeling changes, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances

Diabetes
Updates on safety and regulatory issues related to Diabetes, including product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances

Cardiovascular Disease
Updates on safety and regulatory issues related to Cardiovascular Disease, including product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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Drugs 

BadAd
Updates from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) about its healthcare provider outreach

CDER New
New Items posted to the Center for Drug Evaluation and Research (CDER) website

Drug Information
Occasional drug information updates on hot topics, frequently asked questions, and more

Drug Marketing, Advertising, and Communications
Drug marketing, advertising, and communication regulation information: updates to the DDMAC Web pages

Drug Safety News (Podcast alert)
Emerging safety information about drugs broadcast in conjunction with the release of Public Health Advisories and other drug safety issues

Drug Shortages
Notification about drug products added to the Current Drug Shortages and Resolved Drug Shortages lists

FDA Consumer Education about Medicine
Consumer education on making the best medicine choices, buying safely, and using medicine safely and effectively

FDA Patient Safety News (video)
TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines and diagnostic products

Generic Drug User Fee Act (GDUFA)
Updates on the FDA Generic Drug User Fee Act (GDUFA)

Genomics at FDA
Additions to FDA's Genomics pages

MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories

Medicines in My Home
An interactive and educational program for adolescents and adults about the safe and effective use of over-the-counter medicines

Medication Guides
Notification when new and updated medication guides are added to the FDA list of Medication Guides.

Oncology Drugs
Listing of FDA approved oncology drugs with approved indications

REMS: Approved Risk Evaluation and Mitigation Strategies
Updates to the page "Approved Risk Evaluation and Mitigation Strategies (REMS)"

Small Business and Industry Assistance
Center for Drug Evaluation and Research (CDER) programs and services that affect regulated small pharmaceutical business and industry

Special Features on Drug Topics
Timely and easy-to-read articles covering drug-related issues

Tainted Products Sold as Dietary Supplements
Alerts and FDA actions on tainted products marketed as dietary supplements for weight loss, sexual enhancement, and body building

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Emergency Preparedness 

FDA's Medical Countermeasures Initiative (MCMi) News

Receive email updates when there is new information related to FDA's program to support development and availability of medical products and related medical equipment to counter chemical, biological, radiological, and nuclear events and emerging infectious disease threats.

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FDA Transparency 

CDRH Transparency
Under the FDA Transparency Initiative, the Center for Devices and Radiological Health (CDRH) is releasing additional information to help the public understand its processes and decisions

FDA-TRACK Updates
FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. Get updates to learn about progress on important projects and programs.

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Food and Nutrition

Manufactured Food Regulatory Program Standards (MFRPS)
The Manufactured Food Regulatory Program Standards (MFRPS) are a set of standards developed by the FDA, along with selected state program managers, that can be used by the states as a guide for continuous improvement for state food manufacturing programs.

FDA Food Safety Updates for Health Professionals and Sanitarians
Illinois Food Safety Updates: Illinois - Information on local training events, food safety announcements, and free food safety resources for sanitarians, environmental health, and food safety professionals.

Food Defense and Emergency Coordination
Receive updates on new information, events, and other items of interest related to Food Defense awareness activities, regulations, guidance, policies, tools and other resources that FDA is working on related to intentional contamination. In addition, receive updates related to emergency operations and responses relative to man-made and natural disasters, National Special Security Events (NSSEs), and Incident Command System (ICS) programs.

CFSAN Constituent Update
Food safety and security constituent updates 

CFSAN News for Educators
Receive the bi-monthly education newsletter on topics from FDA’s Center for Food Safety and Applied Nutrition

Dietary Supplements and Food Labeling
Information on labeling requirements for foods under the Federal Food Drug and Cosmetic Act and its amendments

Interstate Certified Shellfish Shippers
Interstate certified shellfish shippers list

Interstate Milk Shippers
Sanitation, compliance and enforcement ratings of interstate milk shippers

Food Safety Modernization Act (FSMA)
Receive updates on new information, events, and other items of interest related to the FDA Food Safety Modernization Act (FSMA). The FSMA was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

Fish and Fishery Products Hazards and Controls Guidance
This guidance represents the agency's current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards. 

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Guidance Documents 
FDA Guidance Documents
FDA Guidance Documents for regulated industry

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Health Fraud Scams 

FDA Health Fraud Scams
Receive updates on health fraud scams including tips for consumers when buying products online, medication health fraud, consumer updates and videos. In addition, receive information on health fraud related press announcements, compliance actions taken including recalls, seizures and injunctions, warning and cyber letters, and information on how to report a problem with fraudulent products regulated by FDA.

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Medical Devices 
CDRH New
The previous business-day's new additions to the CDRH website.

CDRH Industry
Email updates for new or updated content that is specifically related to industry.

CDRH Science
Updates on regulatory science, the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products.

Consumer Information for Medical Devices
Notifications for consumers about medical device information, recently approved devices, and alerts that may be of interest to the general public.

FDA Radiological Health Program
News about radiological products and procedures regulated by FDA, and FDA’s role in radiation safety.

Global UDI Database (GUDID) System Status
Provides email alerts regarding database updates and system status for the Global Unique Device Identification Database.

InVitro Diagnostics
Updates on in-home and laboratory diagnostic tests including 510(k) decision summaries, guidances, and upcoming meetings.

Mammography
Notices about new mammography documents and updates to the CDRH/Mammography website.

Medical Device Epidemiology Network Initiative (MDEpiNet)
Mailing list for MDEpiNet), a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed.

Medical Device Safety and Recalls
Notices on medical device recalls, safety communications, alerts, articles, and other safety information.

Medical Product Safety Network (MedSun)
Adverse event reporting program for the clinical community to identify, understand, and solve problems with the use of medical devices.

Preventing Surgical Fires
Updates on the Preventing Surgical Fires Initiative, its collaborative efforts and other surgical fire safety efforts to reduce preventable harm.

Recent Device Approvals
Information about medical devices that FDA has recently approved.

Unique Device Identification (UDI)
Information on how the use of a Unique Device Identification (UDI) system may improve patient safety.

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MedWatch 
MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories

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News and Events 

FDA Voice
FDA Commissioner Margaret Hamburg, M.D., welcomes you to FDA Voice. The biweekly blog will feature posts by FDA’s senior leadership and staff at home and abroad.

FDA Patient Safety News (video)
TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines and diagnostic products 

FDA Press Releases
Press releases issued by FDA

Food Allergy Alerts
FDA Press Releases, industry press releases specific to food allergy alerts

Food Safety Alerts
FDA Press Releases, industry press releases specific to food safety and food safety alerts

FDA Updates for Health Care Professionals
Recent announcements, medical product approvals, opportunities to comment on proposed rules, upcoming public meetings, and other information of interest to health professionals

Recalls, Market Withdrawals and Safety Alerts
FDA Press Releases, industry press releases on FDA-related products and safety alerts concerning significant (primarily Class I) product recalls/actions

Upcoming Meetings
List of upcoming FDA Advisory Committee meetings and other FDA-related public meetings

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Pediatrics and Ethics 
Pediatrics and Ethics
Latest FDA news on pediatrics and ethics

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Radiological Health 
FDA Radiological Health Program
News about radiological products and procedures, and about FDA's role in radiation safety

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Recalls and Safety Alerts 
FDA Enforcement Report
FDA actions take in connection with agency regulatory activities

FDA Patient Safety News (video)
TV broadcasts for healthcare professionals about recalls, alerts, and ways to improve the safety of drugs, medical devices, vaccines and diagnostic products

Import Alerts
Interested parties may sign up to receive weekly e-mail notifications regarding new Import Alerts and updated existing Import Alerts. The weekly updates will provide links the the new and updated Import Alerts. Due to technical limitations, the e-mail notifications will not provide summaries of changes made to existing alerts.  

Medical Device Recalls
Notices about Class I medical device recalls and some Class II and III recalls of interest to consumers

MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories

Recalls, Market Withdrawals and Safety Alerts
FDA Press Releases, industry press releases on FDA-related products and safety alerts concerning significant (primarily Class I) product recalls/actions

MDEpiNet
Information about the Medical Device Epidemiology Network partnership projects, meetings, and publications

 

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Regulations, Laws and Standards 
FDA Bioterrorism Act
Information and updates about the Bioterrorism Preparedness and Response Act of 2002

FDA Data Standards
Information on the evaluation, development, maintenance, and adoption of health and regulatory data standards to ensure that common data standards are utilized

FDA Warning Letters
FDA Warning Letters issued to companies subject to FDA laws and regulations

O'Hare Import Updates
The monthly O'Hare Import Updates provides importers, brokers, and forwarders information on FDA announcements related to imports, local training opportunities, FDA importer resources, and monthly entry review schedule.

Tobacco Compliance Check Inspection Warning Letters
Warning Letters issued to tobacco retailers for violations observed during a compliance check inspection

Good Clinical Practice
Information about the development of final rules related to FDA's regulations on good clinical practice and clinical trials  

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Research 

ArrayTrack News
NCTR's bioinformatics resource for DNA microarray and systems biology to manage, analyze, and interpret omics data within a single package

Endocrine Disruptor Knowledge Base (EDKB) Resources
Biological activity database, QSAR training sets, and computational models to predict estrogen and androgen activity

FDALabel
Receive updates when new features are added to FDALabel - FDA's web-based application that can be used to query a database of approximately 40,000 drug labels.

Jobs at NCTR
Job opportunities at the National Center for Toxicological Research

NCTR Scientific Publications List
Listing of research manuscripts published by NCTR contributors

NCTR Quarter Page
Quarterly newsletter that highlights NCTR special events, research activities, scientific staff, and publications in scientific journals

NCTR Research Highlights
Updates on recent research-related activities at NCTR

Regulatory Research Perspectives (RRP) Journal
An online journal that enables FDA scientists to communicate with each other and to the global community, scientific research that is important to the agency

What's New in Science and Research
Updates on scientific initiatives and activities across the Agency  

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Tobacco Products 

Tobacco Products Scientific Advisory Committee (TPSAC)
Updates on meetings and activities concerning the committee

This Week in CTP -- Updates from the Center for Tobacco Products
CTP's weekly update on the latest news and announcement from the Center

Tobacco Compliance Check Inspection Warning Letters
Warning Letters issued to tobacco retailers for violations observed during a compliance check inspection

Regulations
Information and updates about the specific regulations covered by the Family Smoking Prevention and Tobacco Control Act

Advertising
Information and updates about tobacco advertising

Labeling
Information and updates about tobacco labeling

Manufacturing
Information and updates specifically for tobacco manufacturers

Retailers
Information and updates specifically for tobacco retailers

Consumers
Information and updates for consumers

Campaigns
Information and updates about campaigns

 

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Women's Health 

General Women's Health  
FDA women's health information for consumers, including program and product updates.

Minority Women's Health
FDA information relevant to African American, American Indian/Alaska Native, Asian American/Pacific Islander, and Hispanic/Latina women, including special programs, campaigns and publications in diverse languages.  

Breast Cancer
FDA health information for consumers, community groups, and healthcare providers about breast cancer  screening and treatment , including updates on the Pink Ribbon Sunday Mammography Awareness program.

Reproductive Health

FDA information related to pregnancy, including pregnancy registries that collect information about medicines used during pregnancy, and reproductive health information including all FDA-approved contraceptives.

Health Professionals

FDA safety alerts, research, actions, and product information, and program updates relevant to women's health professionals, including physicians, nurses, pharmacists and researchers.

College Health

FDA health and program information relevant to college health centers and health education, nursing, and pharmacy programs.

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Generic Drug User Fee Act (GDUFA)
Updates on the FDA Generic Drug User Fee Act (GDUFA) 

Page Last Updated: 10/14/2014
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