February 29, 2024 at 05:01PM ESPEROCT

Intended for use for adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes

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February 29, 2024 at 03:52PM FDA Helps to Deliver Meaningful Advances for Rare Disease Patients

We remain committed to supporting rare disease research, engaging patients and caregivers to understand their unique perspectives, and enhancing our review processes to advance medical products for rare disease patients.

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February 29, 2024 at 02:45PM Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

Clinical Pharmacology

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February 29, 2024 at 01:46PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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February 27, 2024 at 11:53PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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February 27, 2024 at 11:20PM Elecsys Anti-HBc II

Elecsys Anti-HBc II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma.

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Tornado watch issued as severe weather outbreak appears more likely - NBC Chicago

1. Tornado watch issued as severe weather outbreak appears more likely  NBC Chicago
2. Chicago weather radar: NWS issues Tornado Watch for entire area following near-record warmth  WLS-TV
3. Chicago Environment Department tracks unpredictable weather driven by climate change  CBS News
4. Tornado Watch issued for Chicagoland region ahead of developing storms  Fox Weather
5. In Chicago, It's Summer in February  The New York Times

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February 27, 2024 at 09:00PM 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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February 26, 2024 at 12:44PM Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement - 05/16/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 16, 2024 Meeting announcement and meeting materials.

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February 23, 2024 at 09:46PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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February 23, 2024 at 03:39PM 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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February 22, 2024 at 03:49PM Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant.

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February 22, 2024 at 07:32PM Devices Guidances

This page lists Medical Device Guidance documents.

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February 22, 2024 at 05:08PM AMTAGVI

Lifileucel for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

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February 21, 2024 at 06:26PM Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

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February 21, 2024 at 09:15PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

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February 21, 2024 at 02:45PM Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

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February 20, 2024 at 11:10PM FDA Roundup: February 20, 2024

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

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February 20, 2024 at 05:52PM Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop - 02/22/2024

This public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases.

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At least 53 killed in tribal fighting in Papua New Guinea, ABC reports - Reuters

1. At least 53 killed in tribal fighting in Papua New Guinea, ABC reports  Reuters
2. Papua New Guinea ambush: Dozens shot dead in Highlands region  BBC.com
3. Dozens killed in outbreak of tribal violence in Papua New Guinea highlands  The Guardian
4. At least 26 killed in massacre in PNG highlands  ABC News
5. Dozens of men killed in Papua New Guinea tribal violence, Australian media report  NPR

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Dozens of men killed in Papua New Guinea tribal violence, Australian media report - NPR

1. Dozens of men killed in Papua New Guinea tribal violence, Australian media report  NPR
2. Papua New Guinea ambush: More than 60 shot dead in Highlands region  BBC.com
3. Dozens killed in outbreak of tribal violence in Papua New Guinea highlands  The Guardian
4. At least 53 killed in tribal fighting in Papua New Guinea, ABC reports  Reuters
5. Dozens shot dead escalating Papua New Guinea tribal dispute  FRANCE 24 English

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At least 64 killed in ‘largest’ tribal clashes in Papua New Guinea - Al Jazeera English

1. At least 64 killed in ‘largest’ tribal clashes in Papua New Guinea  Al Jazeera English
2. Papua New Guinea ambush: More than 60 shot dead in Highlands region  BBC.com
3. At least 53 killed in tribal fighting in Papua New Guinea, ABC reports  Reuters
4. At Least 53 Men Massacred In Papua New Guinea Tribal Violence: Police  HuffPost
5. Dozens killed in outbreak of tribal violence in Papua New Guinea highlands  The Guardian

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The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese - NPR

1. The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese  NPR
2. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
3. 4 Californians sickened by E. coli outbreak linked to raw milk cheese  CBS News
4. CDC recall Raw Farm's cheddar cheese over E. coli outbreak  Fox Business
5. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY

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The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese - NPR

1. The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese  NPR
2. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
3. 4 Californians sickened by E. coli outbreak linked to raw milk cheese  CBS News
4. CDC recall Raw Farm's cheddar cheese over E. coli outbreak  Fox Business
5. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY

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The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese - NPR

1. The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese  NPR
2. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
3. 4 Californians sickened by E. coli outbreak linked to raw milk cheese  CBS Los Angeles
4. Recalled cheese over listeria concerns expands: See the full list  LiveNOW from FOX
5. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY

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The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese - NPR

1. The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese  NPR
2. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
3. 4 Californians sickened by E. coli outbreak linked to raw milk cheese  CBS Los Angeles
4. CDC recall Raw Farm's cheddar cheese over E. coli outbreak  Fox Business
5. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY

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Do YOU buy this cheddar cheese brand? CDC issues urgent warning after 10 people are infected by E. Coli across - Daily Mail

1. Do YOU buy this cheddar cheese brand? CDC issues urgent warning after 10 people are infected by E. Coli across  Daily Mail
2. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY
3. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
4. 4 Californians sickened by E. coli outbreak linked to raw milk cheese  CBS News
5. CDC recall Raw Farm's cheddar cheese over E. coli outbreak  Fox Business

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Do YOU buy this cheddar cheese brand? CDC issues urgent warning after 10 people are infected by E. Coli across - Daily Mail

1. Do YOU buy this cheddar cheese brand? CDC issues urgent warning after 10 people are infected by E. Coli across  Daily Mail
2. At least 10 sickened in 4 states with E. coli linked to raw milk cheese from Fresno  KMPH Fox 26
3. E. coli outbreak: Raw cheese linked to illnesses in 4 states, FDA, CDC investigation finds  USA TODAY
4. CDC recall Raw Farm's cheddar cheese over E. coli outbreak  Fox Business
5. 2 Utahns sickened in E. coli outbreak linked to raw milk cheese, 10 nationwide  KSL.com

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February 16, 2024 at 11:17PM 5 Things to Know About Triclosan

Triclosan is an ingredient added to many consumer products to help reduce or prevent bacterial contamination. Are there benefits?

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February 16, 2024 at 09:08PM Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020

This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.

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February 16, 2024 at 07:41PM Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

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February 15, 2024 at 04:30PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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February 14, 2024 at 05:08PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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February 13, 2024 at 08:44PM Charging for Investigational Drugs Under an IND - Questions and Answers

Guidance for Industry - Charging for Investigational Drugs Under an IND - Questions and Answers, Procedural

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February 13, 2024 at 06:38PM FDA Roundup: February 13, 2024

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

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Deadly Listeria outbreak prompts dairy product recall at Costco, Walmart and others - Fox Business

1. Deadly Listeria outbreak prompts dairy product recall at Costco, Walmart and others  Fox Business
2. Taco kit recall: Taco kits sold in Alabama recalled for possible listeria contamination  AL.com
3. Products recalled over listeria risk include Austin-based Whole Foods  Austin American-Statesman
4. Recall alert: Dole salad kits recalled due to listeria concerns  WSB Atlanta
5. Dozens more products recalled in relation to deadly outbreak of Listeria infections  Food Safety News

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February 13, 2024 at 03:20PM Barkey GmbH & Co. KG - 657073 - 01/31/2024

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

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Cheese Recall Expands to Dozens of Products As Two People Die - Newsweek

1. Cheese Recall Expands to Dozens of Products As Two People Die  Newsweek
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. Cheese recall: More items removed from shelves over listeria risk  USA TODAY
4. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
5. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle

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Cheese Recall Expands to Dozens of Products As Two People Die - Newsweek

1. Cheese Recall Expands to Dozens of Products As Two People Die  Newsweek
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. Cheese recall: More items removed from shelves over listeria risk  USA TODAY
4. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
5. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle

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Cheese recall: More items removed from shelves over listeria risk - USA TODAY

1. Cheese recall: More items removed from shelves over listeria risk  USA TODAY
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. After 2 Deaths and 23 Hospitalizations Across 11 States, California Company Recalls Dairy Products Due to Listeria Outbreak  Food & Wine
4. Fresh Creative Foods Announces Voluntary Recall of Dressings and Taco Kit Due to Risk of Listeria in Ingredient From Cheese Supplier: Rizo-Lopez Foods, Inc.  FDA.gov
5. Dairy products, salad kits and more linked to deadly Listeria outbreak  KXAN.com

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Cheese recall: More items removed from shelves over listeria risk - USA TODAY

1. Cheese recall: More items removed from shelves over listeria risk  USA TODAY
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. After 2 Deaths and 23 Hospitalizations Across 11 States, California Company Recalls Dairy Products Due to Listeria Outbreak  Food & Wine
4. 2 dead, 23 hospitalized from eating recalled cheese: CDC  KRON4
5. Fresh Creative Foods Announces Voluntary Recall of Dressings and Taco Kit Due to Risk of Listeria in Ingredient From Cheese Supplier: Rizo-Lopez Foods, Inc.  FDA.gov

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Cheese recall: More items removed from shelves over listeria risk - USA TODAY

1. Cheese recall: More items removed from shelves over listeria risk  USA TODAY
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. Salad kit recalled from Kansas Walmarts over listeria risk  KSNT News
4. After 2 Deaths and 23 Hospitalizations Across 11 States, California Company Recalls Dairy Products Due to Listeria Outbreak  Food & Wine
5. 2 dead, 23 hospitalized from eating recalled cheese: CDC  KRON4

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Super bowl staples recalled over listeria outbreak in taco kits, bean dips, dairy products: CDC - Fox News

1. Super bowl staples recalled over listeria outbreak in taco kits, bean dips, dairy products: CDC  Fox News
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. Dairy products, salad kits and more linked to deadly Listeria outbreak  KXAN.com
4. Cheese, Sour Cream and Yogurt Recalled Nationwide—Here's Why  Parade Magazine
5. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle

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Super bowl staples recalled over listeria outbreak in taco kits, bean dips, dairy products: CDC - Fox News

1. Super bowl staples recalled over listeria outbreak in taco kits, bean dips, dairy products: CDC  Fox News
2. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
3. Cheese, Sour Cream and Yogurt are Being Recalled Nationwide—Here's What You Need to Know  Yahoo Life
4. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle
5. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News

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2 dead, 23 hospitalized from eating recalled cheese: CDC - KRON4

1. 2 dead, 23 hospitalized from eating recalled cheese: CDC  KRON4
2. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle
3. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
4. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
5. Cheese, Sour Cream and Yogurt are Being Recalled Nationwide—Here's What You Need to Know  Yahoo Life

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Dairy products, salad kits and more linked to deadly Listeria outbreak - KXAN.com

1. Dairy products, salad kits and more linked to deadly Listeria outbreak  KXAN.com
2. Costco, Trader Joe's and Walmart products made with cheese linked to deadly listeria outbreak  CBS News
3. Listeria outbreak prompts recalls at H-E-B, other Texas grocery stores  Houston Chronicle
4. Cheese, Sour Cream and Yogurt are Being Recalled Nationwide—Here's What You Need to Know  Yahoo Life
5. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov

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February 09, 2024 at 05:14PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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February 08, 2024 at 02:32PM Meeting Materials, Vaccines and Related Biological Products Advisory Committee

These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee

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February 08, 2024 at 05:45PM Evaluating the Host and Microbial Factors That Impact the Efficacy of Polysaccharide Vaccines

A description of Mustafa Akkoyunlu's research program and related publications.

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February 08, 2024 at 03:07PM New Approaches to the Development and Evaluation of Vaccines Against Hepatitis Viruses

A description of Marian Major's research program and related publications.

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February 06, 2024 at 07:31PM Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Clinical Pharmacology

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Long-running listeria outbreak that killed 2 is linked to cotija and queso fresco from a California business - NBC News

1. Long-running listeria outbreak that killed 2 is linked to cotija and queso fresco from a California business  NBC News
2. 2 dead after consuming recalled cheese linked to this outbreak  NJ.com
3. 13 Dairy Brands Recall Products Due to Possible Listeria Contamination  EatingWell
4. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
5. Listeria outbreak prompts recall of cheese, other dairy products: What to know  The Washington Post

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Listeria outbreak prompts recall of cheese, other dairy products: What to know - The Washington Post

1. Listeria outbreak prompts recall of cheese, other dairy products: What to know  The Washington Post
2. Rizo-López Foods, Inc. Voluntarily Recalls Dairy Products Because of Possible Health Risk  FDA.gov
3. 13 Dairy Brands Recall Products Due to Possible Listeria Contamination  EatingWell
4. Listeria outbreak confirmed at Modesto’s Rizo-López Foods  Modesto Bee
5. Cheese recall: Listeria risk for Queso fresco, sour cream and yogurt  USA TODAY

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Recalled dairy products may be linked to listeria outbreak in 7 states, CDC warns - ABC News

1. Recalled dairy products may be linked to listeria outbreak in 7 states, CDC warns  ABC News
2. Listeria outbreak linked to recalled dairy products, including queso fresco and Cotija cheese  CNN
3. Cheese recall: Listeria risk for Queso fresco, sour cream and yogurt  USA TODAY
4. Listeria outbreak confirmed at Modesto’s Rizo-López Foods  Modesto Bee
5. Listeria outbreak across more than 10 states linked to recalled dairy products: CDC  The Hill

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February 06, 2024 at 05:14AM Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)

This page lists the Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay) infectious disease tests products with supporting documents.

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February 06, 2024 at 04:57AM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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February 06, 2024 at 03:27PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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February 05, 2024 at 10:03PM Administrative Guidances

This page lists Administrative Guidance documents.

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February 05, 2024 at 05:25PM Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Pharmacology/Toxicology (OPT) is recruiting to fill multiple Staff Fellow/Visiting Associate positions to serve as Pharmacology/Toxicology Reviewers.

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February 05, 2024 at 04:50PM 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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February 02, 2024 at 09:00PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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February 01, 2024 at 08:29PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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