March 31, 2025 at 04:30PM Blood Safety & Availability

Blood Safety & Availability

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March 31, 2025 at 02:11PM Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank - 680039 - 06/10/2024

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

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March 31, 2025 at 01:48PM Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

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March 31, 2025 at 01:21PM Questions about Tissues

Information about tissues, questions and answers, donor screening and testing, donor eligibility

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March 28, 2025 at 07:50PM 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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March 28, 2025 at 03:59PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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March 28, 2025 at 02:29PM Questions about Blood

FDA is responsible for ensuring the safety of the Nation's blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA to protect and enhance the safety of blood products.

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Helicopter crashes in North Gyeongsang while fighting wildfires, pilot killed - The Korea JoongAng Daily

1. Helicopter crashes in North Gyeongsang while fighting wildfires, pilot killed  The Korea JoongAng Daily
2. Race to save lives and cultural treasures from South Korea's worst ever fires  BBC.com
3. South Korea battles worst ever wildfires as death toll hits 26  Reuters
4. Outbreak of Fire Across South Korea  nasa.gov
5. South Korea faces uphill battle to contain massive wildfires as death toll rises to 26  New York Post

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Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 24 dead - CNN

1. Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 24 dead  CNN
2. South Korea is in uphill battle to contain massive wildfires as the death toll rises to 26  Yahoo
3. Outbreak of Fire Across South Korea  nasa.gov
4. South Korea fires: 18 dead as acting president speaks of ‘unprecedented damage’  The Guardian
5. At least 26 dead as South Korea's largest ever wildfires rage  BBC.com

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Trump Administration Abruptly Cuts Billions From State Health Services - The New York Times

1. Trump Administration Abruptly Cuts Billions From State Health Services  The New York Times
2. Lubbock health official says federal funding cuts will hurt efforts to contain measles outbreak  The Texas Tribune
3. Trump administration pulls back billions in Covid-era funding for state, local health departments  CNN
4. New Hampshire faces new budget gap after federal government cuts off $80M in grants  WMUR Manchester
5. Federal government to pull back $125 million in COVID money from Illinois health departments  Chicago Tribune

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Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 24 dead - CNN

1. Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 24 dead  CNN
2. Outbreak of Fire Across South Korea  nasa.gov
3. Watch: Historic Buddhist temple burns in South Korea wildfires  BBC.com
4. South Korea fires: 18 dead as acting president speaks of ‘unprecedented damage’  The Guardian
5. South Korea Wildfires Kill Dozens of People  The New York Times

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Strong winds fan South Korea wildfires, death toll climbs to 18 - Reuters

1. Strong winds fan South Korea wildfires, death toll climbs to 18  Reuters
2. At least 18 dead in South Korea's 'worst ever fires'  BBC.com
3. Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 19 dead  CNN
4. Outbreak of Fire Across South Korea  nasa.gov
5. 2 firefighters die in South Korea as dry winds fuel dozens of wildfires  The Associated Press

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Strong winds fan South Korea wildfires, death toll climbs to 18 - Reuters

1. Strong winds fan South Korea wildfires, death toll climbs to 18  Reuters
2. South Korea: at least 18 dead in 'worst' fires in nation's history  BBC.com
3. Centuries-old Buddhist temple destroyed as ‘unprecedented’ South Korea wildfires leave at least 19 dead  CNN
4. Outbreak of Fire Across South Korea  nasa.gov
5. Wildfires ravage South Korea, killing 18 and destroying a 1,300-year-old temple  NPR

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Strong winds fan South Korea wildfires as death toll climbs to 18 - Reuters

1. Strong winds fan South Korea wildfires as death toll climbs to 18  Reuters
2. South Korea fires: 18 dead as acting president speaks of ‘unprecedented damage’  The Guardian
3. Outbreak of Fire Across South Korea  nasa.gov
4. Residents in South Korea’s Andong city told to evacuate as wildfires spread  The Associated Press
5. Fire response level raised to highest as wildfires spread  The Korea Herald

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South Korea fires: 18 dead as acting president speaks of ‘unprecedented damage’ - The Guardian

1. South Korea fires: 18 dead as acting president speaks of ‘unprecedented damage’  The Guardian
2. Death toll in South Korea wildfires rises to 16  Reuters
3. Outbreak of Fire Across South Korea  nasa.gov
4. Residents in South Korea’s Andong city told to evacuate as wildfires spread  The Associated Press
5. Deadly wildfires sweep across South Korea’s southeast, in photos and videos  The Washington Post

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March 24, 2025 at 08:24PM Ignatius P. Godoy, M.D. - 561662 - 10/01/2018

Bioresearch Monitoring Program/IRB  


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March 24, 2025 at 05:11PM 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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March 24, 2025 at 02:23PM HIZENTRA

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

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March 21, 2025 at 06:50PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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March 21, 2025 at 06:34PM Antimicrobial Resistance

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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March 20, 2025 at 07:25PM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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March 19, 2025 at 08:52PM Vibrant Health Care, Inc. - 608426 - 11/18/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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March 19, 2025 at 04:45PM Washington Fertility Center - 678931 - 04/30/2024

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

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March 18, 2025 at 07:13PM Kedbumin

Product approval information is indicated for:
o Hypovolemic shock
o Hypoalbuminemia
o Prevention of central volume depletion after paracentesis due to cirrhotic ascites
o Ovarian Hyperstimulation Syndrome (OHSS)
o Adult Respiratory Distress Syndrome (ARDS)
o Burns
o Hemodialysis patients undergoin

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March 18, 2025 at 02:20PM MG Infusions - 696890 - 03/10/2025

CGMP/Deviations/Biologics License Application (BLA)

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March 18, 2025 at 02:12PM CBER Advanced Technologies Team (CATT)

To provide an interactive mechanism within CBER for prospective innovators/developers of advanced manufacturing technologies to discuss the implementation of these technologies in the development of CBER-regulated products.

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March 17, 2025 at 05:04PM Instructions for Using the eBPDR System

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manu

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Storm system to exit US, leaving behind at least 39 dead and vast destruction from tornadoes, wildfires and dust storms - CNN

1. Storm system to exit US, leaving behind at least 39 dead and vast destruction from tornadoes, wildfires and dust storms  CNN
2. At least 40 are dead as severe weather sweeps across the U.S.  MSNBC
3. Storms slam Northeast with hurricane-force wind gusts on third, final day of deadly severe weather outbreak  Fox Weather
4. Trump activates National Guard in tornado-ravaged Arkansas as 37 deaths reported across multiple states  Fox News
5. Photos: Storms weave a trail of destruction across the US  Al Jazeera English

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Residents survey the aftermath of deadly weekend storms across the southern U.S. - NPR

1. Residents survey the aftermath of deadly weekend storms across the southern U.S.  NPR
2. Storms slam Northeast with hurricane-force wind gusts on third, final day of deadly severe weather outbreak  Fox Weather
3. Severe Weather System Brings High Winds and Tornado Threat to the East Coast  The New York Times
4. At least 32 dead in massive US storm after new fatalities reported in Kansas and Mississippi  The Associated Press
5. Storm system impacting NYC area wreaked havoc across the country  CBS New York

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At least 36 killed as tornadoes, severe weather threaten multiple states - Axios

1. At least 36 killed as tornadoes, severe weather threaten multiple states  Axios
2. US tornadoes, wildfires and dust storms leave 37 dead and 'staggering' damage  BBC.com
3. News Wrap: Deadly storm system leaves trail of destruction across U.S.  PBS NewsHour
4. Storms slam Northeast with hurricane-force wind gusts on third, final day of deadly severe weather outbreak  Fox Weather
5. Twelve people dead across Missouri following Friday storms, Highway Patrol says  KOMU 8

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Tornado outbreak live updates: 40 tornadoes, 31 dead in cross-country storm system - ABC News

1. Tornado outbreak live updates: 40 tornadoes, 31 dead in cross-country storm system  ABC News
2. Severe storms leave trail of destruction across South, Midwest  CBS New York
3. At least 32 dead in massive US storm after new fatalities reported in Kansas and Mississippi  The Associated Press
4. Severe weather sparks tornadoes and wind-fueled fires, with Southern U.S. on alert  NPR
5. Death toll grows to 33 as destructive storms and violent tornadoes obliterate the South and Midwest  New York Post

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Fierce Storms Kill at Least 18 as Tornadoes Batter the South and Midwest - The New York Times

1. Fierce Storms Kill at Least 18 as Tornadoes Batter the South and Midwest  The New York Times
2. At least 32 dead in massive US storm after new fatalities reported in Kansas and Mississippi  The Associated Press
3. At least 26 killed as tornadoes and dust storms rip through parts of US  Sky News
4. Severe weather sparks tornadoes and wind-fueled fires, with Southern U.S. on alert  NPR
5. Live Updates: Deadly Tornado Outbreak Fans Out To Southeast  The Weather Channel

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Gov. Stitt gives update on Oklahoma wildfires - 4029tv

1. Gov. Stitt gives update on Oklahoma wildfires  4029tv
2. State of emergency issued after more than 130 fires spark Friday across Oklahoma  KOCO Oklahoma City
3. Gov. Stitt visits own ranch, destroyed by wildfires  news9.com KWTV
4. More than 50 homes lost in Stillwater-area fires  Stillwater News Press
5. Dry conditions, powerful winds brought a wildfire outbreak to parts of Oklahoma  KFOR Oklahoma City

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At least 1 dead as severe storms sweep through the Midwest - ABC News

1. At least 1 dead as severe storms sweep through the Midwest  ABC News
2. 3 dead in Missouri after monster tornadoes caught on video sweeping through state amid severe weather outbreak  Fox Weather
3. Midwest Residents Wake Up To Tornado Deaths, Destruction  The Weather Channel
4. St. Louis County declares state of emergency  First Alert 4
5. At least six dead as threat of tornadoes moves south and blinding winds fan wildfires  NBC News

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Extreme weather expected Saturday gets rarely used ‘high risk’ designation - The Associated Press

1. Extreme weather expected Saturday gets rarely used ‘high risk’ designation  The Associated Press
2. Tornado threat moves south after central states hit by massive storm  Fox News
3. Mid-March Severe Weather Outbreak Map Tracker  The Weather Channel
4. At least six dead as threat of tornadoes moves south and blinding winds fan wildfires  NBC News
5. Severe weather — including high winds — moves through central U.S.  The Washington Post

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'I've never done this in my career' - NWS meteorologist sends out dire warning about Friday severe weather - KSDK.com

1. 'I've never done this in my career' - NWS meteorologist sends out dire warning about Friday severe weather  KSDK.com
2. States of emergency issued as 150 million faces risk of terrible tornadoes during 'prolific' multiday outbreak  Fox Weather
3. Severe weather whips up Texas fires, threatens tornadoes in nation's midsection  NBC News
4. Mid-March Severe Weather Outbreak Map Tracker  The Weather Channel
5. Big March storm fans wildfires and flips trucks as forecasters fear weekend tornado outbreak  The Associated Press

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Severe weather expected across central, eastern U.S. through weekend - The Washington Post

1. Severe weather expected across central, eastern U.S. through weekend  The Washington Post
2. States of emergency issued as 150 million faces risk of terrible tornadoes during 'prolific' multiday outbreak  Fox Weather
3. Extreme weather and powerful winds predicted for 100m Americans  The Guardian US
4. Big March storm fans wildfires and flips trucks as forecasters fear weekend tornado outbreak  The Associated Press
5. 'I've never done this in my career' - NWS meteorologist sends out dire warning about Friday severe weather  KSDK.com

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A strengthening storm is whacking Plains with hurricane-force winds and dust ahead of a likely tornado outbreak in the South - CNN

1. A strengthening storm is whacking Plains with hurricane-force winds and dust ahead of a likely tornado outbreak in the South  CNN
2. Storm timeline: When and where severe weather is expected near St. Louis  KTVI Fox 2 St. Louis
3. Rare ‘high risk’ severe storm outbreak could fuel intense twisters  Yahoo News Canada
4. FIRST ALERT 6 WEATHER DAY: A quick line of strong storms moves through Friday afternoon  WOWT
5. 100 million at risk from severe weather, tornadoes Friday, Saturday  Axios

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100 million at risk from severe weather, tornadoes Friday, Saturday - Axios

1. 100 million at risk from severe weather, tornadoes Friday, Saturday  Axios
2. A strengthening storm threatens intense, long-lasting tornadoes, hurricane-force winds and a wildfire outbreak starting today  CNN
3. Severe weather expected across central, eastern U.S. through weekend  The Washington Post
4. 150 million brace for 'prolific' severe weather outbreak Friday amid multiday threat of long-track tornadoes  Fox Weather
5. Live: Tornado Threat, Winter Storm In Plains  The Weather Channel

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March 14, 2025 at 04:25PM 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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Big March storm system threatens U.S. with tornadoes, blizzards and wildfire risk - NPR

1. Big March storm system threatens U.S. with tornadoes, blizzards and wildfire risk  NPR
2. Big March storm system threatens US with tornadoes, blizzards and wildfire risk  Yahoo
3. Millions across the US brace for heavy rain and possible tornadoes  TODAY
4. Severe Outbreak Could Spawn Several Tornadoes, Widespread Wind Damage  The Weather Channel
5. A severe weather outbreak begins Friday. Where storm and tornado risk is highest.  The Washington Post

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March 13, 2025 at 01:18PM 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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White House pulls CDC director nomination on day of confirmation hearing - NBC News

1. White House pulls CDC director nomination on day of confirmation hearing  NBC News
2. White House Withdraws Nominee for C.D.C. Director  The New York Times
3. Scoop: White House to pull CDC director nomination  Axios
4. CDC nominee to face questions about measles outbreak, vaccine policy  The Washington Post
5. CDC Director Nominee Testifies at Confirmation Hearing  C-SPAN

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March 12, 2025 at 10:39PM ALTUVIIIO

For adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding.

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March 12, 2025 at 06:39PM CBER 2025 Orphan Approvals (new BLAs)

CBER 2025 Orphan Approvals (new BLAs)

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March 11, 2025 at 08:24PM FDA Roundup: March 11, 2025

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

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March 11, 2025 at 01:14PM Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity Reactions

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

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Trump administration scraps over 80% of USAID programs, top diplomat Rubio says - Reuters

1. Trump administration scraps over 80% of USAID programs, top diplomat Rubio says  Reuters
2. The Diseases Are Coming  The Atlantic
3. How Foreign Aid Cuts Are Setting the Stage for Disease Outbreaks  The New York Times
4. Rubio says Trump administration canceling 83% of programs at USAID and intends to move remaining ones to State Department  CNN
5. Rubio thanks DOGE, says US is canceling most USAID programs  POLITICO

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March 10, 2025 at 08:26PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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March 07, 2025 at 09:22PM Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Guidance for Industry - Labeling

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March 06, 2025 at 05:20PM Signature Biologics, LLC - 631039 - 02/21/2025

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

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March 06, 2025 at 05:18PM Signature Biologics, LLC - 631039 - 09/18/2023

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

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Powerful US storms create blizzard conditions and threaten to spawn more tornadoes - The Associated Press

1. Powerful US storms create blizzard conditions and threaten to spawn more tornadoes  The Associated Press
2. Millions in path of deadly storm bringing fierce winds, blizzard conditions and tornado warnings  CNN
3. Severe weather outbreak across South kills 2 as tornadoes wreak havoc in multiple states  Fox Weather
4. Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday  NPR
5. Thunderstorms, heavy rain hit East Coast with blizzard conditions in the Midwest  ABC News

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Powerful US storms create blizzard conditions and threaten to spawn more tornadoes - The Associated Press

1. Powerful US storms create blizzard conditions and threaten to spawn more tornadoes  The Associated Press
2. Millions in path of deadly storm bringing fierce winds, blizzard conditions and tornado warnings  CNN
3. Powerful U.S. storms create blizzard conditions and threaten to spawn more tornadoes  Pittsburgh Post-Gazette
4. Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday  NPR
5. Severe Weather Outbreak Maps Tracker: Radar, Forecasts, Alerts And More  The Weather Channel

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Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday - NPR

1. Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday  NPR
2. Millions in path as storm kills 2, brings fierce winds, blizzard conditions and fires  CNN
3. Winter storm causes widespread power outages in Texas and may bring blizzard conditions to central U.S., elevate wildfire risk in southern states  Yahoo
4. Powerful US storms kill 2, bring threats from critical fire weather to blizzard conditions  The Associated Press
5. Severe Weather Outbreak Maps Tracker: Radar, Forecasts, Alerts And More  The Weather Channel

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Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday - NPR

1. Blizzards, wildfires and thunderstorms are expected across the nation on Wednesday  NPR
2. Texas besieged by multiple fires as deadly storm fuels severe weather and blizzard conditions  CNN
3. Alert Day: Strong storms expected late on Fat Tuesday  WLOX
4. Severe Weather Outbreak Maps Tracker: Radar, Forecasts, Alerts And More  The Weather Channel
5. Storm Brings Risks of Wildfires, Blizzards and Tornados for much of the U.S.  The New York Times

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March 04, 2025 at 10:33PM FDA Roundup: March 4, 2025

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

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Storm Brings Risks of Wildfires, Blizzards and Tornados for much of the U.S. - The New York Times

1. Storm Brings Risks of Wildfires, Blizzards and Tornados for much of the U.S.  The New York Times
2. Massive storm with hurricane-force winds strengthens, damaging buildings as it threatens blizzard, fires and tornadoes  CNN
3. Tornadoes, damaging winds possible as severe storms threaten Southeast through Wednesday  WGME
4. Winter storm causes widespread power outages in Texas and may bring blizzard conditions to central U.S., elevate wildfire risk in southern states  Yahoo
5. Severe Weather Outbreak Maps Tracker: Radar, Forecasts, Alerts And More  The Weather Channel

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