About FDA

Get Email Updates

Our free e-mail alert service allows you to receive important FDA news and information as they become available. To sign up, please select the topics that interest you below.

To subscribe, all you need is a valid e-mail address. Your e-mail will only be used to deliver the requested information or to give you access to your subscription preferences. Visit FDA’s privacy policy for more details.

 

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)

Clinical Pharmacology Corner
Occasional updates from CDER’s Office of Clinical Pharmacology regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest

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

Back to Top

 

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

Back to Top

 

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.

Información de Salud para el Consumidor de la FDA
Artículos oportunos y fáciles de leer sobre la aprobación y seguridad de productos médicos, alimentos, suplementos dietéticos, cosméticos, vacunas, sangre, productos de tabaco y para animales, así como otra información de salud para la mujer y los niños.

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.

Back to Top

 

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

Back to Top

 

Dietary Supplements 
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

Back to Top

 

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.

Back to Top

 

Drugs 

BadAd
Updates from the FDA's Office of Prescription Drug Promotion (OPDP) about its healthcare provider outreach

CDER Drug Safety Labeling Changes
Updates from CDER on approved Drug Safety Labeling Changes

CDER Regulatory Science Initiatives
Updates from CDER on regulatory science opportunities and initiatives

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

Clinical Pharmacology Corner
Occasional updates from CDER’s Office of Clinical Pharmacology regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest

Common REMS Platform Initiative
Updates on the development of the Common REMS Platform and related events

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

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

Drug Trials Snapshots
Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.

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 Amendments of 2012 (GDUFA)
Updates on the FDA Generic Drug User Fee Amendments of 2012 (GDUFA)

Generic Drugs Updates
Updates on the activities of the FDA Generic Drugs Program

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.

Office of Prescription Drug Promotion
Office of Prescription Drug Promotion regulation information: updates to the OPDP Web pages

Oncology Drugs
Listing of FDA approved oncology drugs with approved indications

Pharmacy Compounding
Updates from FDA regarding compounding regulations and actions

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

Back to Top

 

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.

Back to Top

 

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.

Back to Top

 

FDA Foodborne Illness Outbreak Investigation 

FDA Foodborne Illness Outbreak Investigation
Receive updates on FDA foodborne illness outbreak investigations. Updates are provided as new information becomes available and include the most recent information available on the investigation, the number of illnesses, and advice for consumers and, when appropriate, for industry.

Back to Top

 

Food and Nutrition
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

FDA Foodborne Illness Outbreak Investigation
Receive updates on FDA foodborne illness outbreak investigations. Updates are provided as new information becomes available and include the most recent information available on the investigation, the number of illnesses, and advice for consumers and, when appropriate, for industry.

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. 

Retail Food Protection
FDA assists regulatory agencies (and the industries they regulate) with retail food protection by providing a model Food Code, scientifically-based guidance, training, program evaluation, and technical assistance. Receive updates on topics related to retail food protection, including: Food Code (and the Food Code Reference System), Program Standards, the FDA Retail Risk Factor Study and more.

Back to Top

 

Guidance Documents 
FDA Guidance Documents
FDA Guidance Documents for regulated industry

Back to Top

 

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.

Back to Top

 

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

Medical Device Single Audit Program (MDSAP)
Email notifications when MDSAP documents are updated.

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.

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.

Back to Top

 

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

Back to Top

 

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

Back to Top

 

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

Back to Top

 

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

Lasers
Receive updates pertaining to all forms of lasers.

Back to Top

 

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

FDA Foodborne Illness Outbreak Investigation
Receive updates on FDA foodborne illness outbreak investigations. Updates are provided as new information becomes available and include the most recent information available on the investigation, the number of illnesses, and advice for consumers and, when appropriate, for industry.

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

 

Back to Top

 

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  

Back to Top

 

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

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

Back to Top

 

Tobacco Products 

This Week in CTP
Be among the first to receive news from the Center as it happens, in our “This Week in CTP” bulletin and bimonthly CTPConnect newsletter.

Compliance and Enforcement Updates
Receive timely updates with information about regulatory activities, compliance dates and resources, industry education and training, and more.

Science and Research Updates
Stay current on CTP’s tobacco regulatory science and research efforts, including getting our quarterly newsletter, Spotlight on Science, direct to your inbox.

Back to Top

 

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.

Back to Top

 

Generic Drug User Fee Amendments of 2012 (GDUFA)
Updates on the FDA Generic Drug User Fee Amendments of 2012 (GDUFA) 

Page Last Updated: 11/16/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English