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Animal and Veterinary Health Biologics Color Additives Consumer Health Data Cosmetics Dietary Supplements Diseases and Conditions Drugs FDA Transparency Food and Nutrition Guidance Documents Medical Devices MedWatch Safety Alerts Information 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 information 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 details about blood publications and FDA’s Blood Action Plan

Blood Products Advisory Committee
Info 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 utilization 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.
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.

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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 data. 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 data on a variety of matters, including new product approvals Tiffany Ring, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other details of curiosity 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

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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 below 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.

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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

CDER Small Business
Center for Drug Evaluation and Research (CDER) programs and services that affect small business

Drug Information
Occasional drug details updates on hot subjects, frequently asked questions, and more.

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

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

Drug Safety Newsletter
Postmarket details for healthcare professionals on new drug safety data and reported adverse events

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

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 utilization of over-the-counter medicines.

Oncology Drugs
Listing of FDA approved oncology drugs with approved indications

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, ######ual enhancement, and body building.

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FDA Transparency

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

FDA Basics Updates
Obtain updates on FDA 101 and learn about how the FDA works

FDA-TRACK Updates
FDA-TRACK is actually 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
CFSAN Constituent Update
Food safety and security constituent updates

Dietary Supplements and Food Labeling
Details on labeling requirements for foods below 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)
Obtain updates on new details, events, and other items of curiosity 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.



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Guidance Documents
FDA Guidance Documents
FDA Guidance Documents for regulated industry

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

Contact Lenses
News about safety issues and details about recent approvals and innovations

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

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

Mammography
Notices about new mammography documents and updates to the CDRH/Mammography Web site

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

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

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 Tiffany And Co, and other safety information

Personal Protective Equipment
Info about personal protective equipment for use in patient care

Public Health Notifications
Notices for the health care community on risks associated with certain medical devices and how to avoid or reduce those risks

Recent Device Approvals
Info on recently approved medical devices

TV Studio Events (Center for Devices and Radiological Health)
Upcoming FDA broadcasts from the CDRH studio

Unique Device Identification
Updates on Unique Device Identification (UDI)

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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 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 details of curiosity 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

TV Studio Events (Center for Devices and Radiological Health)
Upcoming FDA broadcasts from the CDRH studio

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 information on pediatrics and ethics

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Radiological Health
FDA Radiological Health Program
Information 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

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

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

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

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

Tobacco Compliance Check out Inspection Warning Letters

Warning Letters issued to tobacco retailers for violations observed during a compliance verify inspection

Good Clinical Practice
Data 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 information 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 supply quality control tools for the generation, analysis, and application of microarray data

NCTR's Center for Bioinformatics
Bioinformatics tools obtainable on the Web

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

NCTR Quarterpage
Quarterly newsletter that highlights NCTR special events Pandora Jewellery Rings, 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 permits FDA scientists to communicate with each other and to the global community, scientific research that is crucial to the agency

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Tobacco Products

Tobacco Compliance Check Inspection Warning Letters

Warning Letters issued to tobacco retailers for violations observed during a compliance examine 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
Info and updates specifically for tobacco manufacturers

Retailers
Details and updates specifically for tobacco retailers

Consumers
Information and updates for consumers

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Women's Health

FDA Women's Health Updates
Program updates from the FDA Office of Women's Health and FDA safety alerts and product info for women.

FDA Women's Health Updates for African American Women
FDA Information relevant to African American Women, including special programs and campaigns.

FDA Women's Health Updates for Asian American/ Pacific Islander Women
FDA Details relevant to Asian American/ Pacific Islander Women including special programs, campaigns and publications in AA/PI languages.

FDA Women's Health Updates for American Indian/Alaska Native Women
FDA Info relevant to American Indian/Alaska Native Women, including special programs and campaigns

FDA Women's Health Updates for Hispanic/Latina Women
FDA Information relevant to Hispanic/Latina Women including special programs, campaigns and publications in Spanish.

FDA Women's Health Updates for Health Professionals
FDA safety alerts, product data, and program updates relevant to women’s health professionals, including physicians, nurses, pharmacists and researchers.

FDA Women's Health Updates for Industry
FDA women’s health safety alerts Discount Tiffany, product info and program info for industry.

Women & Aging
FDA health Data for older women, caregivers, and geriatric healthcare providers.

Women & Cancer
Cancer screening, diagnosis, and treatment Info for women and healthcare providers.

Women & Diabetes
Diabetes prevention and treatment Info for women and healthcare providers.

Women & Heart Disease
Heart disease prevention, diagnosis, and treatment data for women and healthcare providers.

Breast Cancer Screening and Treatment
FDA health information for consumers, community groups, and healthcare providers, including updates on the Pink Ribbon Sunday Mammography Awareness program.

College Health
FDA health and program details relevant to college health centers and health education, nursing, and pharmacy programs.

Menopause
FDA info on menopause and menopause hormone therapy.

Mental Health Updates for Women
Mental health info for women and healthcare providers, including updates about medicines to treat depression.

Osteoporosis
FDA details on osteoporosis screening, prevention, and treatment.

Pregnancy
FDA Information related to pregnancy, including pregnancy registries that collect information about medicines employed during pregnancy.

Reproductive Health
Reproductive health details including all FDA-approved contraceptives.

Safe Medicine Use for Women
FDA info on medication safety for women and programs updates from the FDA Office of Women’s Health “Take Time To Care” program.

Women's Health Research
Updates on research projects funded by the FDA Office of Women's Health

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