October 31, 2023 at 10:40PM FDA Roundup: October 31, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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October 31, 2023 at 02:41PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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October 30, 2023 at 04:26PM ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

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October 27, 2023 at 06:15PM INFANRIX

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

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October 27, 2023 at 02:47PM Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.

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October 27, 2023 at 02:13PM Questions about Vaccines

Information on general and specific vaccines

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October 26, 2023 at 05:41PM Seraclone Blood Grouping Reagent Anti-S (Monoclonal)

Product approval information is indicated for the determination of the blood group antigens on red blood cells using the tube test.

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October 26, 2023 at 05:06PM FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

The agency is advising the public, including healthcare providers, of the possible risks that products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings.

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Death toll in Gaza approaches 7000 as aid groups raise alarm about fuel - NPR

1. Death toll in Gaza approaches 7000 as aid groups raise alarm about fuel  NPR
2. Food and Water Grow Scarce in Gaza Amid Israeli Siege and Strikes  The New York Times
3. Gaza: doctors use phone torches as hospitals run out of fuel for generators  Guardian News
4. Besieged Gaza Strip running short of bread and drinking water  Euronews
5. Outbreak of disease seen among displaced Gazans, say doctors  WION
6. View Full Coverage on Google News

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October 25, 2023 at 08:46PM Abbott Laboratories - 669353 - 10/24/2023

Dietary Supplement/Adulterated


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October 25, 2023 at 05:59PM Devices Guidances

This page lists Medical Device Guidance documents.

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October 24, 2023 at 08:50PM Moderna COVID-19 Vaccine

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

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October 24, 2023 at 08:25PM FDA Roundup: October 24, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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October 24, 2023 at 05:44PM CDRH Issues Updated Final Guidance on Breakthrough Devices Program

The final guidance is intended to help FDA and our customers leverage the interactive nature of the program to further advance health equity.

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October 23, 2023 at 10:32PM Allergy Relief for Your Child

Do you have a sneezing, stuffy-nosed child? He or she may have allergies. Learn more about proven treatments for children.

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October 23, 2023 at 08:19PM Advances in Saving Lives with Blood

An FDA official in the Office of Blood Research and Review discusses promising technologies involving blood and blood products, from extending the life of blood products to using DNA technology to better match donors and recipients.

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October 23, 2023 at 04:28PM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP).

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October 20, 2023 at 11:41PM Facts about COVID-19

Facts about COVID-19 vaccines, including ingredients, safety and more

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October 20, 2023 at 05:54PM GLASSIA

Product approval information is indicated for treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin.

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October 20, 2023 at 05:03PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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October 20, 2023 at 02:30PM Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 5, 2023 announcement and meeting materials.

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October 19, 2023 at 03:01PM Tissue Guidances

This page contains a listing of tissue related guidances.

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October 19, 2023 at 02:52PM Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

This is the Guidance for Industry - Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

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October 17, 2023 at 09:34PM FDA Roundup: October 17, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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October 17, 2023 at 05:39PM Clinical Review - Fluarix

•For active immunization of persons 3 years of age and older for the prevention of disease caused by influenza virus subtypes A and type B contained in the vaccine.

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October 17, 2023 at 05:36PM FDA Voices

Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

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October 17, 2023 at 05:34PM Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

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October 17, 2023 at 02:36PM Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

This is the final guidance Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

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October 16, 2023 at 02:45PM Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol

COVID-19

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October 13, 2023 at 04:13PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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October 13, 2023 at 03:53PM Investigational COVID-19 Convalescent Plasma

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.


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October 12, 2023 at 10:20PM BsUFA Performance Reports

BsUFA Performance Reports

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October 11, 2023 at 04:53PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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October 10, 2023 at 11:00PM Biologics Electronic Reading Room (eFOIA)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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October 10, 2023 at 05:02PM Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.

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October 05, 2023 at 11:00PM Risk of Invasive Disease in Preterm Infants Given Probiotics Formulated to Contain Live Bacteria or Yeast

The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants in hospital settings.

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October 05, 2023 at 09:39PM Clinical Guidances

This page lists Clinical Guidance documents.

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October 05, 2023 at 08:29PM Devices Guidances

This page lists Medical Device Guidance documents.

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October 05, 2023 at 07:02PM Remarks by Commissioner Califf at the Reagan Udall Foundation's Public Meeting on Strategies for Improving Public Understanding of FDA-Regulated Products - 10/05/2023

Remarks by Robert M. Califf, MD
The Reagan Udall Foundation
Virtual Public Meeting: Strategies for Improving Public Understanding of FDA-Regulated Products
October 5, 2023
White Oak, MD

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October 05, 2023 at 01:54PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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October 04, 2023 at 08:24PM FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

The FDA is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing late-phase product development issues.

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October 04, 2023 at 07:53PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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October 04, 2023 at 07:05PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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Bedbug fears grip Paris as French minister pledges action - CNBC

1. Bedbug fears grip Paris as French minister pledges action  CNBC
2. Paris suffering severe bedbug outbreak  CBS News
3. Bedbug panic sweeps Paris as infestations soar before 2024 Olympics  BBC.com
4. How to handle a bedbug infestation in your French home  The Local France
5. In Paris, bed bugs appear to be everywhere!  CBS Chicago
6. View Full Coverage on Google News

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October 04, 2023 at 02:38PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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South Africa culls about 7.5M chickens in effort to contain bird flu outbreaks - AOL

South Africa culls about 7.5M chickens in effort to contain bird flu outbreaks  AOLView Full Coverage on Google News

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October 03, 2023 at 09:03PM FDA Roundup: October 3, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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October 03, 2023 at 08:38PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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October 02, 2023 at 08:06PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

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October 03, 2023 at 03:39PM CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients

This policy guide sets forth the position of FDA with respect to products composed of ingredients which were shipped in interstate commerce and were then used in the manufacture of a finished product.

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October 03, 2023 at 01:31PM Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting Announcement - 10/05/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 5, 2023 announcement and meeting materials.

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Paris is crawling with bedbugs. They're even riding the trains. - CBS News

1. Paris is crawling with bedbugs. They're even riding the trains.  CBS News
2. Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics  The Washington Post
3. France sees a jump in bedbugs, as Paris prepares to host the Olympics next year  NPR
4. Paris Fighting Off Citywide Bedbug Outbreak: 'No One Is Safe'  The Daily Beast
5. Paris battles bed bugs after sightings across city  USA TODAY
6. View Full Coverage on Google News

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October 02, 2023 at 06:17PM Marketing Category

This is the list of marketing categories which may be used in Structured Product Labeling (SPL) documents which are sent to FDA.

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Paris Fighting Off Citywide Bedbug Outbreak: 'No One Is Safe' - The Daily Beast

1. Paris Fighting Off Citywide Bedbug Outbreak: 'No One Is Safe'  The Daily Beast
2. Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics  The Washington Post
3. France sees a jump in bedbugs, as Paris prepares to host the Olympics next year  NPR
4. Paris is crawling with bedbugs. They're even riding the trains.  CBS News
5. Paris Tackles Bedbug Infestation as Videos Emerge  Newsweek

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Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics - The Washington Post

1. Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics  The Washington Post
2. Paris Fighting Off Citywide Bedbug Outbreak: 'No One is Safe'  The Daily Beast
3. France sees a jump in bedbugs, as Paris prepares to host the Olympics next year  NPR
4. France launches battle plan against bedbug invasion  The Local France
5. French government combats bedbug epidemic in Paris, urges calm  Fox News

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Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics - The Washington Post

1. Bedbugs in Paris and Marseille cause concern ahead of 2024 Olympics  The Washington Post
2. Paris Fighting Off Citywide Bedbug Outbreak: 'No One is Safe'  The Daily Beast
3. France sees a jump in bedbugs, as Paris prepares to host the Olympics next year  NPR
4. France launches battle plan against bedbug invasion  The Local France
5. French government combats bedbug epidemic in Paris, urges calm  Fox News
6. View Full Coverage on Google News

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France sees a jump in bedbugs, as Paris prepares to host the Olympics next year - NPR

1. France sees a jump in bedbugs, as Paris prepares to host the Olympics next year  NPR
2. Paris Fighting Off Citywide Bedbug Outbreak: 'No One is Safe'  The Daily Beast
3. French government combats bedbug epidemic in Paris, urges calm  Fox News
4. France launches battle plan against bedbug invasion  The Local France
5. French officials fight a bedbug invasion ahead of the Paris Olympics  NBC News
6. View Full Coverage on Google News

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