Tuesday, July 30, 2024

Boar's Head Provisions Co. Expands Recall for Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination | Food Safety and Inspection Service - fsis.usda.gov

  1. Boar's Head Provisions Co. Expands Recall for Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination | Food Safety and Inspection Service  fsis.usda.gov
  2. Boar's Head recalls 7 million pounds of deli meat after being linked to listeria outbreak  Fox Business
  3. Over 200,000 Pounds of Deli Meats Recalled Nationwide Due to Listeria Contamination  EatingWell
  4. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  5. Mass. delis closed again as Boar's Head expands meat recall  WCVB Boston


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Stop & Shop, Big Y delis in Massachusetts closed again in wake of Boar's Head recall - WCVB Boston

  1. Stop & Shop, Big Y delis in Massachusetts closed again in wake of Boar's Head recall  WCVB Boston
  2. Boar's Head expands recall to include 7 million more pounds of deli meats tied to listeria outbreak  The Associated Press
  3. Boar's Head recall expanded to dozens of meat and poultry products amid listeria outbreak  CBS News
  4. Over 200,000 Pounds of Deli Meats Recalled Nationwide Due to Listeria Contamination  EatingWell
  5. Listeria Outbreak Linked to Meats Sliced at Delis  CDC


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July 30, 2024 at 09:36PM FDA Roundup: July 30, 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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July 30, 2024 at 06:01PM ABRYSVO

ABRYSVO is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, and pregnant individuals at 32 through 36 weeks gestational age.


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Saturday, July 27, 2024

Elderly couple files first lawsuit in Boar’s Head’s multistate listeria outbreak over ‘damage to the marital relationship’ - New York Post

  1. Elderly couple files first lawsuit in Boar’s Head’s multistate listeria outbreak over ‘damage to the marital relationship’  New York Post
  2. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  3. Boar's Head recalls 200K pounds of deli meat over listeria contamination concerns  Fox Business
  4. Deli meat listeria recall: Which products are included  WDIV ClickOnDetroit
  5. Deli meat sample from Maryland tests positive for listeria, health officials say  WBAL TV Baltimore


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Elderly couple files first lawsuit in Boar’s Head’s multistate listeria outbreak over ‘damage to the marital relationship’ - New York Post

  1. Elderly couple files first lawsuit in Boar’s Head’s multistate listeria outbreak over ‘damage to the marital relationship’  New York Post
  2. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  3. Deli meat sample from Maryland tests positive for listeria, health officials say  WBAL TV Baltimore
  4. Boar's Head recalls more than 207,000 pounds of meat due to listeria concerns  NBC News
  5. Boar's Head recalls 200K pounds of deli meat over listeria contamination concerns  Fox Business


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Stop & Shop stores reopen delis after deep cleaning due to Boar’s Head recall - Boston 25 News

  1. Stop & Shop stores reopen delis after deep cleaning due to Boar’s Head recall  Boston 25 News
  2. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  3. Harris Teeter temporarily stops deli services everywhere: Here’s why  WBTV
  4. Grocery store chains close delis in Massachusetts for cleaning after Boar's Head recall  WCVB Boston
  5. Boar's Head recalls 200,000 pounds of deli meat linked to a Listeria outbreak  NPR


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Friday, July 26, 2024

Boar’s Head recalls 200K deli meats after Listeria is detected. Throw out these cold cuts. - NJ.com

  1. Boar’s Head recalls 200K deli meats after Listeria is detected. Throw out these cold cuts.  NJ.com
  2. Boar's Head recalls more than 207,000 pounds of meat due to listeria concerns  NBC News
  3. At least a dozen in New York hospitalized in listeria outbreak. Where in the state the cases are located  CBS New York
  4. Harris Teeter temporarily stops deli services everywhere: Here’s why  WBTV
  5. Listeria Outbreak Linked to Meats Sliced at Delis  CDC


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Amid Deadly Listeria Outbreak, Boar’s Head Recalls Some Deli Meats - The New York Times

  1. Amid Deadly Listeria Outbreak, Boar’s Head Recalls Some Deli Meats  The New York Times
  2. Harris Teeter temporarily stops deli services everywhere: Here’s why  WBTV
  3. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  4. Boar's Head recalls 200,000 pounds of deli meat linked to a Listeria outbreak  NPR
  5. Grocery store chains close delis in Massachusetts for cleaning after Boar's Head recall  WCVB Boston


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Boar's Head recalls 200,000 pounds of deli meat linked to a Listeria outbreak - NPR

  1. Boar's Head recalls 200,000 pounds of deli meat linked to a Listeria outbreak  NPR
  2. Stop & Shop temporarily closes deli counters for cleaning amid multi-state listeria outbreak  NBC New York
  3. Listeria Outbreak Linked to Meats Sliced at Delis  CDC
  4. Stop & Shop closes all store delis after Boar’s Head recall over listeria fears  New York Post
  5. Harris Teeter temporarily stops deli services everywhere: Here’s why  WBTV


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July 26, 2024 at 03:52PM Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use

This is the Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use.

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July 26, 2024 at 03:48PM FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products

This is the FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products

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Thursday, July 25, 2024

July 25, 2024 at 05:14PM Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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Wednesday, July 24, 2024

July 24, 2024 at 03:46PM Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

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July 24, 2024 at 02:45PM Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Real World Data/Real World Evidence

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Sunday, July 21, 2024

Two dead in multistate listeria outbreak linked with sliced deli meat, CDC says - Local 3 News

Two dead in multistate listeria outbreak linked with sliced deli meat, CDC says  Local 3 NewsView Full Coverage on Google News

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Mass. residents among those sick in deadly multi-state listeria outbreak linked to deli meats - MassLive.com

  1. Mass. residents among those sick in deadly multi-state listeria outbreak linked to deli meats  MassLive.com
  2. Two dead in multistate listeria outbreak linked with sliced deli meat, CDC says  CNN
  3. Two deaths linked to listeria food poisoning from meat sliced at deli counters  The Associated Press
  4. A listeria outbreak linked to deli meat has two dead and hit New York, 11 other states  Miami Herald
  5. 1 sickened in NC, dozens fall ill from listeria possibly linked to deli meat in multiple states  WTVD-TV


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Fear of contamination in water| IDF to vaccinate soldiers in Gaza for Polio - Arutz Sheva

  1. Fear of contamination in water| IDF to vaccinate soldiers in Gaza for Polio  Arutz Sheva
  2. Cease-fire. The only way to prevent polio epidemic among Gazan and Israeli babies | Opinion  Haaretz
  3. Israeli military to offer polio vaccination to soldiers in Gaza  Reuters
  4. Discovery of polio in Gaza further threatens besieged Palestinians  USA TODAY
  5. Poliovirus Traces Detected in Gaza, Raising Fears of Outbreak  Bloomberg


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July 21, 2024 at 04:55PM Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry

This is the Guidance for Industry, Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma

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Thursday, July 18, 2024

July 18, 2024 at 03:00PM Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

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Wednesday, July 17, 2024

July 17, 2024 at 02:21PM Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

This is the guidance Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

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Tuesday, July 16, 2024

July 16, 2024 at 10:24PM Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials.

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July 16, 2024 at 03:20PM Massachusetts Institute of Technology MIT - 663218 - 06/21/2024

Bioresearch Monitoring Program/IRB

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Chicago Weather: 1 dead in NW Ind. as storms that prompted tornado warnings cause widespread damage - WLS-TV

  1. Chicago Weather: 1 dead in NW Ind. as storms that prompted tornado warnings cause widespread damage  WLS-TV
  2. Deadly Derecho Wreaks Havoc In Midwest  The Weather Channel
  3. Thousands without power after ‘rare' severe weather outbreak across Chicago  NBC Chicago
  4. WATCH: 7 tornadoes observed in Chicagoland, drone footage shows major damage from Monday night’s powerful storms  WGN TV Chicago
  5. 215,000 without power after severe storms spawn multiple tornadoes Monday night  Daily Herald


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July 16, 2024 at 02:44PM Application User Fees for Combination Products

Revised final guidance on PDUFA and MDUFA application user fees for combination products. For combination products with a single or separate application(s), it explains how FDA applies user fees.

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July 16, 2024 at 02:28PM Emergency Dispensing Orders and Emergency Use Instructions (EUI)

The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

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Monday, July 15, 2024

July 15, 2024 at 03:57PM Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, CBER, Biologics

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Thursday, July 11, 2024

July 12, 2024 at 12:40AM Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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July 11, 2024 at 04:00PM Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024

FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

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Tuesday, July 9, 2024

July 10, 2024 at 12:13AM 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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July 09, 2024 at 03:32PM Charter of the Vaccines and Related Biological Products Advisory Committee

This is the Charter of the Vaccines and Related Biological Products Advisory Committee.

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July 09, 2024 at 03:20PM New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank - 681776 - 06/20/2024

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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Monday, July 8, 2024

July 08, 2024 at 08:25PM Consumer Updates

Science-based health and safety information you can trust.

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July 08, 2024 at 04:58PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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Wednesday, July 3, 2024

July 04, 2024 at 12:12AM Executive Order 14017 on America’s Supply Chains

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

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Tuesday, July 2, 2024

July 01, 2024 at 09:17PM 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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July 02, 2024 at 05:26PM 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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Monday, July 1, 2024

Outbreak of Injuries Leaves U.S. With a Veteran Gymnastics Team for Paris Olympics - The Wall Street Journal

  1. Outbreak of Injuries Leaves U.S. With a Veteran Gymnastics Team for Paris Olympics  The Wall Street Journal
  2. Suni Lee, Shilese Jones and the toughest-ever U.S. Olympic gymnastics team to make  ESPN
  3. Team USA announces Paris Olympics artistic gymnastics team  WLWT Cincinnati
  4. U.S. Women's Olympic Team Named at the conclusion of 2024 U.S. Olympic Team Trials – Gymnastics • USA Gymnastics  usagym.org
  5. Who Is on the 2024 U.S. Olympic Women's Gymnastics Team?  The Cut


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U.S. gymnast Simone Biles qualifies for Paris 2024 Olympics - The Associated Press

  1. U.S. gymnast Simone Biles qualifies for Paris 2024 Olympics  The Associated Press
  2. Suni Lee, Shilese Jones and the toughest-ever U.S. Olympic gymnastics team to make  ESPN
  3. Outbreak of Injuries Leaves U.S. With a Veteran Gymnastics Team for Paris Olympics  The Wall Street Journal
  4. U.S. Olympic Gymnastics Trials: Read the Full Recap  PEOPLE
  5. The Team USA Women Gymnasts Who Qualified for the Paris Olympics  Harper's BAZAAR


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