FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

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[2-21-2019] The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.

As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S.1 The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

Patients should tell your health care professional if you have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout.

Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.

When we approved Uloric in 2009, we included a Warning and Precaution regarding possible cardiovascular events in patients treated with Uloric in the current prescribing information and required the drug manufacturer, Takeda Pharmaceuticals, to conduct a large postmarket safety clinical trial. The trial was conducted in more than 6,000 patients with gout treated with either Uloric or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention, called unstable angina.

The results showed that overall, Uloric did not increase the risk of these combined events compared to allopurinol (See Data Summary). However, when the outcomes were evaluated separately, Uloric showed an increased risk of heart-related deaths and death from all causes. In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year. In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol. This safety trial was also discussed at a public Advisory Committee meeting of outside experts on January 11, 2019.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving Uloric or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

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[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.

Febuxostat is FDA-approved to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the blood.

Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.

The febuxostat drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, we required an additional safety clinical trial after the drug was approved and on the market to better understand these differences, and that trial was finished recently.

The safety trial was conducted in over 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.

We are continuing to evaluate this safety issue and will update the public when we have more information. We urge health care professionals and patients to report side effects involving febuxostat or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm

[email protected] Download File (new structure)

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[unable to retrieve full-text content]https://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM527389.zip

Additions/Deletions for Prescription and OTC Drug Product Lists

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https://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm

Americans Tightened Their Belts And It Might Hurt Economic Numbers Important To Trump

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Retail sales fell 1.2 percent in December, the most in nine years. The drop cut into forecasts for economic growth. David Zalubowski/AP hide caption

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David Zalubowski/AP

Retail sales fell 1.2 percent in December, the most in nine years. The drop cut into forecasts for economic growth.

David Zalubowski/AP

What started off as a strong holiday shopping season ended with a whimper, as consumers, rattled by a trade war and a government shutdown, tightened their belts. The Commerce Department said retail sales fell 1.2 percent between November and December, the sharpest drop in nine years.

The slowdown in consumer spending put a dent in overall economic growth. Forecasters at the Federal Reserve Bank of Atlanta lowered their estimate of fourth-quarter growth to just 1.5 percent. If that holds, growth for all of 2018 would fall short of the Trump administration’s 3 percent target.

“It appears that worries over the trade war and turmoil in the stock markets impacted consumer behavior more than we expected,” National Retail Federation President Matthew Shay said in a statement. “It’s very disappointing that clearly avoidable actions by the government influenced consumer confidence and unnecessarily depressed December retail sales.”

Retailers had reported robust sales in the first half of the holiday season. But consumers grew more cautious when a political standoff over border wall funding temporarily shuttered parts of the federal government just before Christmas. This followed a roller-coaster ride on Wall Street, as investors worried that trade tensions between the U.S. and China would cut into corporate profits.

“The combination of financial market volatility, the government shutdown and trade tensions created a trifecta of anxiety and uncertainty impacting spending,” said National Retail Federation chief economist Jack Kleinhenz.

The 35-day government shutdown delayed the release of the retail figures. But the Commerce Department said the shutdown did not compromise the quality of the survey. Retailers were not so certain.

“This is an incomplete story,” Kleinhenz said. “We will be in a better position to judge the reliability of the results when the government revises its 2018 data in the coming months.”

White House economic adviser Larry Kudlow shrugged off the downbeat numbers.

“The overall economy is very strong,” he told Fox News. “Investment is strong. Consumption is strong despite this number, which has so many glitches in it.”

While Kudlow maintained an outward show of confidence, he also said he’s pleased that the Federal Reserve has stopped raising interest rates for the time being. The sharp drop in December’s retail sales is likely to reinforce the Fed’s more cautious approach.

Boosting economic growth has been a top priority for the Trump administration. Growth accelerated to 4.2 percent in the spring of last year, thanks in part to the GOP tax cut and increased government spending.

While the White House argues faster growth can be sustained, many observers believe the effects are a temporary “sugar high” that will soon wear off. Growth in the third quarter slowed to 3.4 percent. A preliminary estimate of fourth-quarter growth will be released on Feb. 28.

Provided By NPR

Newly Added Guidance Documents

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Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

**JANUARY 2019 GUIDANCES:

IMMUNOGENICITY TESTING OF THERAPEUTIC…

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2009-D-0539, for this document, which is accessible on www.Regulations.gov

Labeling for Human Prescription Drugs…

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2018-D-4603, for this document which is accessible on www.Regulations.gov




Newly Added Guidance Documents

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.






https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

ICE Detention Beds New Stumbling Block In Efforts To Prevent Another Shutdown

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With some Democrats calling to abolish Immigration and Customs Enforcement, congressional negotiators want to cap the number of the agency’s detention beds. Scott Olson/Getty Images hide caption

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Scott Olson/Getty Images

With some Democrats calling to abolish Immigration and Customs Enforcement, congressional negotiators want to cap the number of the agency’s detention beds.

Scott Olson/Getty Images

Updated at 5:03 p.m. ET

As the clock ticks toward a Friday deadline to avert another partial government shutdown, a new stumbling block has emerged in talks between congressional Democrats and the White House: Immigration and Customs Enforcement detention beds.

The Trump administration said last month that it wanted $4.2 billion to support 52,000 detention beds. “Given that in recent months, the number of people attempting to cross the border illegally has risen to 2,000 per day, providing additional resources for detention and transportation is essential,” the White House said.

But Democrats are seeking to cap the number of detention beds. In a statement Sunday, Rep. Lucille Roybal-Allard, D-Calif., asserted that “A cap on ICE detention beds will force the Trump administration to prioritize deportation for criminals and people who pose real security threats, not law-abiding immigrants who are contributing to our country.”

Roybal-Allard chairs the House Appropriations subcommittee on homeland security and is a member of the House-Senate conference committee trying to reach an agreement on spending levels.

Democrats want to limit to 16,500 the number of beds used in the interior of the country, where ICE places people it arrests who have overstayed their visas or committed misdemeanor crimes. Roybal-Allard charges the Trump administration with

“pursuing an out-of-control deportation policy focused on removing immigrants with no criminal records, many of whom have deep roots in their communities. This approach is cruel and wrong. A cap on detention beds associated with interior enforcement will rein in the Trump administration’s deportation agenda.”

Democrats say a cap of 16,500 would restore immigration enforcement to levels in place at the end of the Obama administration. A House Democratic aide speaking on background said Democratic and Republican negotiators had agreed to reduce funding overall for ICE detentions to a range between 34,000 and 38,500 beds by the end of the year.

In a briefing call on Monday, ICE Deputy Director Matt Albence said any cap on detention beds would be “extremely damaging to public safety.” He said ICE is currently detaining 20,000 to 22,000 individuals in the interior of the country, away from the border.

In a Sunday interview on Fox Business, Sen. Lindsey Graham, R-S.C., said of the Democratic position, “Not only is it enough they want to abolish ICE. They want to abolish the bed spaces available to the country to house violent offenders so they can be held and deported.” Graham added, “I promise you this: Donald Trump is not going to sign any bill that reduces the number of bed spaces available to hold violent offenders who come across our border. He can’t do that. He won’t do that, and you can take that to the bank.”

President Trump tweeted on Monday that “The Democrats do not want us to detain, or send back, criminal aliens! This is a brand new demand. Crazy!”

But Democrats say they want nothing of the sort. Roybal-Allard said the cap will ensure that the Trump administration “targets violent felons and other people who pose security risks for deportation, instead of pursuing reckless mass deportation policies that actually make us less safe.”

Provided By NPR

Why Period Activists Think The ‘Drop Of Blood’ Emoji Is A Huge Win

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The red drop of blood (left) was designated as an official emoji to symbolize menstruation, among other things, this year. The design at right, submitted in 2017, was not accepted. Unicode; Plan International UK hide caption

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Unicode; Plan International UK

The red drop of blood (left) was designated as an official emoji to symbolize menstruation, among other things, this year. The design at right, submitted in 2017, was not accepted.

Unicode; Plan International UK

When Mashiyat Rahman, 22, texts her friends about her period, she sends them the “crying” emoji to describe her mood, the “knife” emoji to describe painful cramps and the “sweat” emoji — which looks like water droplets — to illustrate a heavy flow.

But there’s never been a specific emoji that she could use to represent menstruation — until now. The Unicode Consortium, the organization that decides which symbols get to be emojis, released its 2019 additions this week.

A “drop of blood” emoji has been added to the mix. According to Unicode, the symbol may be used to signify “menstruation” as well as “blood donations” and “medicine.” It should be available on many smartphones in the second half of the year, Unicode said.

While many menstrual health activists are excited about the new emoji, some have reservations about the design.

“Being able to express ourselves using this emoji could make it easier to talk about menstruation,” says Rahman, who runs a menstrual health organization in Bangladesh. “Even though it’s a small step, it’s one of many we should take to break down stigma.”

The emoji didn’t just pop up overnight. The international group Plan International UK, which advocates for children’s rights and girls’ rights — including reducing menstrual stigma in the developing world — has been fighting for what they’ve dubbed the #periodemoji over the past two years.

It’s not uncommon for nonprofits to lobby for emojis. The Bill and Melinda Gates Foundation (which is a funder of this blog) proposed a mosquito emoji to help raise awareness for mosquito-borne diseases like dengue and malaria in 2017. It became an emoji in 2018.

“Emojis play a crucial role in our digital and emotional vocabulary, transcending cultural and country barriers. A period emoji can help normalize periods in everyday conversation,” said Carmen Barlow, digital strategy and development manager at Plan UK, in a statement.

In 2017, the group started a petition to make the period emoji a thing. The group came up with different designs — a pad with a blood stain, a calendar with blood drops and underwear with blood droplets, for example — and asked people to vote for them.

Plan UK’s petition garnered 54,600 signatures. And most of the supporters voted for the underwear with the blood droplets. But Unicode did not accept the design.

When asked why they rejected Plan UK’s original period design, Unicode did not answer the question directly but president and co-founder Mark Davis responded by email: “Emoji proposals are accepted based on the strength of the proposal alone and are not impacted by petitions and lobbying.”

Then in September 2018, Plan UK teamed up with NHS Blood and Transplant, the U.K. government’s blood and organ donations service, and submitted a new proposal for a blood drop emoji. Unicode selected it as an official emoji in February.

Many menstrual advocates love it. “I think it’s fantastic,” says Marni Sommer, a menstrual health researcher and a professor at Columbia University’s Mailman School of Public Health. “It continues the process that many of us have been working on: normalizing the conversation around periods.”

Rahman can already see how she can use the emoji in infographics and digital presentations and in a new menstruation education app she’s working on. She is the head of a group called Resurgence Bangladesh, which aims to break stereotypes around menstruation by hosting workshops that teach girls, boys and their families about reproductive health in urban and rural slums around Dhaka.

She says most of the girls she works with — including those in rural settings — have access to mobile phones. “The emojis aren’t just a Western thing,” she says. “Middle-school and high school children here use their phones a lot — and I can see how they can use it in texting and communicating.”

Yet some researchers are annoyed that the new emoji also represents blood. “It’s not specifically menstrual fluid,” says Chris Bobel, a menstrual health researcher and author of a new book called The Managed Body: Developing Girls and Menstrual Health in the Global South. “It’s multipurpose — could be used for blood transfusions, nosebleeds.”

On Twitter, women shared what they wished the period icon could look like instead.

Still, it doesn’t dampen Bobel’s excitement for the emoji. “Change is a slow erosion,” she says. “I’m cheering for it.”

Provided By NPR

Protests Move To Alabama’s State Capitol After Officer Cleared In Shooting Death

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Residents of Hoover, Ala., have been protesting for months over the shooting death of Emantic Fitzgerald Bradford Jr. On Tuesday, a report by the state attorney general exonerated the police officer who shot Bradford.

On Thanksgiving night, Emantic Fitzgerald Bradford Jr. was shot and killed by a police officer responding to gunfire in the mall. Protesters are angry at a new report that exonerates the officer.

(Image credit: Kim Chandler/AP)

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER March 27, 2019 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Agenda

The committee will discuss new drug application (NDA) 208646, submitted by AllerQuest, LLC, for a skin-test kit (proposed trade name PRE-PEN Plus) that combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium, for the proposed indication to detect IgE sensitization to penicillin antigens and reliably rule out the potential for immediate life-threatening penicillin allergic reactions with a high degree of probability in patients with history of possible IgE-dependent penicillin allergy. The discussion will include study design considerations, the contribution of each of the components, and whether the submitted data provide substantial evidence of efficacy.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-0218. The docket will close on March 26, 2019. Submit either electronic or written comments on this public meeting by March 26, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 26, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before March 13, 2019 will be provided to the committee. Comments received after that date but by March 26, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-0218 for “Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 5, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 6, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the March 27, 2019 meeting of the Pulmonary-Allergy Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: https://www.fda.gov/AdvisoryCommittees/default.htm.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Chee (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm630693.htm

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