martes, 22 de diciembre de 2015

Indoor Tanning Bed Restrictions and more in the December FDA Women's Health Update

Office of Women's Health, FDA
December 2015

Message from the Director

As we closeout another year, FDA continues to work to
protect the public’s health by proposing new rules on indoor
tanning beds and educating health professionals and the
general public about product safety. Check out this final
update for 2015 and look to us in the New Year for exciting
new activities and resources on clinical trialspregnancy
and more.
Marsha Henderson, Assistant Commissioner for Women’s Health


FDA Proposes Tanning Bed 

Age Restrictions and Other 

Important Safety Measures

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Indoor tanning is a known contributor
to skin cancer, including melanoma
(its most deadly form), and other skin
damage. On December 18, the FDA
issued two proposed rules ‎to protect
public health by preventing the use of
sunlamp products (also commonly
known as indoor tanning beds) by
minors and reducing the risk of using
these devices for adults. 
The first proposed rule would restrict use of sunlamp
products to individuals 18 and older. In addition, before
their first tanning session and every six months thereafter,
adult users over age 18 would have to sign a risk
acknowledgement certification that states that they have
been informed of the risks to health that may result from
use of sunlamp products. A second proposed rule would
require that sunlamp manufacturers and tanning facilities
take additional measures to improve the overall safety of
these devices.

New MQSA Insights on Mammography

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The Mammography Quality Standards
Act’s (MQSA) program posts
MQSA Insights articles to provide
information about national inspection
results and frequently-requested
national statistical data for the general
public, press, researchers, and healthcare
providers. The goal of the MQSA Insights
is to help facilities improve the quality of
mammography by allowing them to see
how facilities as an aggregate are doing
across the nation as well as through
exploring specific mammography topics.

WebMD Interview on Cosmetics

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As a part of their Expert Q&A series,
WebMD talked with Linda Katz, MD, the
director of the FDA’s Office of Cosmetics
and Colors, on the safety of beauty products.
The interview highlighted what FDA does
to protect consumers from unsafe cosmetics
and how women can report serious problems
caused by cosmetic products.

FDA launches precisionFDA

FDA recently launched precisionFDA, an online,
cloud-based, portal that will allow scientists from
industry, academia, government and other partners
to come together to foster innovation and develop
the science behind a method of “reading” DNA known
as next-generation sequencing (or NGS). PrecisionFDA
provides the genomics community with a secure
platform where participants can access and share
datasets, analysis pipelines, and bioinformatics tools,
in order to benchmark their approaches and advance
regulatory science.

FDA Meetings

January 25, 2016 - FDA White Oak Campus, Silver Spring, MD

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