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Topics on this Page:
- Animal and Veterinary Health
- Biologics
- Color Additives
- Consumer Health Information
- Cosmetics
- Dietary Supplements
- Diseases and Conditions
- Drugs
- Emergency Preparedness
- FDA Transparency
- Food and Nutrition
- Guidance Documents
- Medical Devices
- MedWatch Safety Alerts
- News and Events
- Pediatrics and Ethics
- Radiological Health
- Recalls and Safety Alerts
- Regulations, Laws and Standards
- Research
- Tobacco Products
- Women's Health
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
Color Additives
Color Additive News
Color Additives announcements and recent additions to the color additives web site.
Color Certification Reports (quarterly)
Quarterly Reports on the Certification of Color Additives from Foreign and Domestic Manufacturers, from FDA/CFSAN's Office of Cosmetics and Colors
Companies Requesting Color Certification Within the Last Two Years
The companies listed have requested and received FDA certification of their color additives within the two years prior to the date of this update
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.
Cosmetics
FDA/CFSAN Cosmetics News
FDA/CFSAN Cosmetics Announcements and Recent Additions to the Cosmetics Web Site
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
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.
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
CDER Small Business
Center for Drug Evaluation and Research (CDER) programs and services that affect small business
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
Preventing Surgical Fires
Updates on the Preventing Surgical Fires Initiative, its collaborative efforts and other surgical fire safety efforts to reduce preventable harm.
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
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.
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 Basics Updates
Receive updates on FDA 101 and learn about how the FDA works
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.
Food and Nutrition
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.
Guidance Documents
FDA Guidance Documents
FDA Guidance Documents for regulated industry
Medical Devices
Breast Implants
Upcoming events, panel meetings, and safety information
CDRH New
The previous business-day's additions to the CDRH Web site
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.
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
Contact Lenses
News about safety issues and information about recent approvals and innovations
eMDR – electronic Medical Device Reporting
The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports.
Event Problem Codes
Updates on enhanced device and patient problem codes. The FDA has provided this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes "go live" and are accepted in MAUDE.
FDA Patient Safety News
This mailing list notifies subscribers when new programs in the FDA Patient Safety News series are available for viewing. FDA Patient Safety News is a televised series for health care personnel featuring information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.
FDA Radiological Health Program
News about radiological products and procedures regulated by FDA, and FDA’s role in radiation safety.
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 Web site
MDUFA III - Medical Device User Fee Amendments
Updates on the Medical Device User Fee Amendments of 2012, or MDUFA III.
Medical Device Epidemiology Network Initiative
Mailing list for the Medical Device Epidemiology Network Initiative (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 Recalls
Notices about Class I medical device recalls and some Class II and III recalls of interest to consumers
Medical Device Safety
FDA’s resource for healthcare professionals on medical device recalls, alerts, articles, and other safety information
MedSun
Adverse event reporting program for the clinical community to identify, understand, and solve problems with the use of medical devices
MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories
Personal Protective Equipment
Information about personal protective equipment for use in patient care
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 on recently approved medical devices
Registration & Listing
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments.
Reprocessing of Single-Use Devices
Information about the reprocessing of single-use medical devices (SUDs).
Unique Device Identification
Updates on Unique Device Identification (UDI)
MedWatch
MedWatch Safety Alerts
Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories
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
Pediatrics and Ethics
Pediatrics and Ethics
Latest FDA news on pediatrics and ethics
Radiological Health
FDA Radiological Health Program
News about radiological products and procedures, and about FDA's role in radiation safety
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
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
ArrayTrack News
NCTR's bioinformatics resource for DNA microarray and systems biology to manage, analyze, and interpret omics data within a single package
ArrayTrack Publications
Publications related to the ArrayTrack genomics tool
Endocrine Disruptor Knowledge Base (EDKB) Resources
Biological activity database, QSAR training sets, and computational models to predict estrogen and androgen activity
MicroArray Quality Control (MAQC) Project
A scientific community-wide effort to provide quality control tools for the generation, analysis, and application of microarray data
NCTR's Center for Bioinformatics
Bioinformatics tools available on the Web
NCTR Scientific Publications List
Listing of research manuscripts published by NCTR contributors
NCTR Quarterpage
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
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
FDA women's health information for consumers, including program and product updates.
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.
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.
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.
FDA safety alerts, research, actions, and product information, and program updates relevant to women's health professionals, including physicians, nurses, pharmacists and researchers.
FDA health and program information relevant to college health centers and health education, nursing, and pharmacy programs.
Generic Drug User Fee Act (GDUFA)
Updates on the FDA Generic Drug User Fee Act (GDUFA)