Tornado Destroys Homes, Kills at Least One in Kansas - The New York Times

1. Tornado Destroys Homes, Kills at Least One in Kansas  The New York Times
2. Extensive damage, 1 confirmed death from Westmoreland tornado  WIBW
3. 1 killed, several injured in Kansas after tornado destroys homes during multi-day severe weather threat  Fox Weather
4. One dead, three hurt after tornado strikes Westmoreland  KSNT News
5. 1 dead, 3 injured in Kansas tornado on fifth day of vortex outbreak  NBC News

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April 30, 2024 at 09:26PM FDA Roundup: April 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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April 30, 2024 at 04:04PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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April 30, 2024 at 04:02PM Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable for use by you, manufacturers of blood and blood components, subject to United States statutes and regulations, the document entitled “United States Industry Consensus Standard for the Uniform Labeling

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Tornado outbreak leaves path of destruction in Midwest, South - TODAY

1. Tornado outbreak leaves path of destruction in Midwest, South  TODAY
2. Businesses step up to help family of 4-month-old who died in Holdenville tornado  KOCO Oklahoma City
3. Marietta, Oklahoma, tornado rated EF-4  Fox Weather
4. Oklahoma tornadoes: Aerial footage shows trail of destruction  BBC.com
5. 'Wondering If I Was Going To Die': Sulphur Business Owner Recalls Moments Storm Destroyed Business And Trapped Her Under Rubble  news9.com KWTV

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Tornadoes kill 4 in Oklahoma, leaving trail of destruction and thousands without power - The Associated Press

1. Tornadoes kill 4 in Oklahoma, leaving trail of destruction and thousands without power  The Associated Press
2. Midwest, Plains Tornado Outbreak: 4 Killed Amid Devastation - Videos from The Weather Channel  The Weather Channel
3. 'Wondering If I Was Going To Die': Suplphur Business Owner Recalls Moments Storm Destroyed Business And Trapped Her Under Rubble  news9.com KWTV
4. Oklahoma Tornadoes: At least 4 dead, 100 injured across the state  KOCO Oklahoma City
5. 'The most damage since I've been Governor that I've seen', destruction in Sulphur  KOKH FOX25

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Oklahoma tornadoes: Aerial footage shows trail of destruction - BBC.com

1. Oklahoma tornadoes: Aerial footage shows trail of destruction  BBC.com
2. Midwest, Plains Tornado Outbreak: 4 Killed Amid Devastation - Videos from The Weather Channel  The Weather Channel
3. Devastation and chaos: Oklahoma hit by series of tornadoes, hundreds injured  The Times of India
4. Downtown Sulphur Closed To Prevent Looting, Authorities Say  news9.com KWTV
5. 'The most damage since I've been Governor that I've seen', destruction in Sulphur  KOKH FOX25

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At least 4 people are dead after tornadoes slam Oklahoma, Iowa and Nebraska - NPR

1. At least 4 people are dead after tornadoes slam Oklahoma, Iowa and Nebraska  NPR
2. Midwest, Plains Tornado Outbreak: 4 Killed Amid Devastation - Videos from The Weather Channel  The Weather Channel
3. At least 4 dead after night of tornadoes, storms in the Midwest  NBC News
4. Okla. counties in state of emergency after deadly tornadoes; severe thunderstorms head to Texas  Yahoo! Voices
5. 'Damage Is Unbelievable': Devastation Seen In Sulphur, Murray County, After Saturday Storms  News On 6

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Oklahoma tornadoes kill 4; state of emergency issued amid damage - The Associated Press

1. Oklahoma tornadoes kill 4; state of emergency issued amid damage  The Associated Press
2. Oklahoma Tornadoes: At least 4 dead, 100 injured across the state  KOCO Oklahoma City
3. Tornado causes extensive damage in Marietta, Oklahoma  CBS News
4. Midwest, Plains Tornado Outbreak: 4 Killed Amid Devastation - Videos from The Weather Channel  The Weather Channel
5. Eufaula Tornado: News On 6 Viewers Share Photos, Video Of Possible Tornado On Sunday  News On 6

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Severe weather update April 27 update at 8:06 pm - KOAM News Now

1. Severe weather update April 27 update at 8:06 pm  KOAM News Now
2. Tornado Outbreak Expected Overnight In Plains, Midwest - Videos from The Weather Channel  The Weather Channel
3. Dangerous storms trigger flash flooding, severe weather over Plains  Fox Weather
4. Kansas City may see all types of severe storms, tornadoes, Saturday  KMBC Kansas City
5. Tornado threat continues after 4 injured, hundreds of homes damaged  Yahoo! Voices

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Dangerous storms expected to trigger flash flooding, severe weather over Plains - Fox Weather

1. Dangerous storms expected to trigger flash flooding, severe weather over Plains  Fox Weather
2. Tornado Outbreak Expected Overnight In Plains, Midwest - Videos from The Weather Channel  The Weather Channel
3. Kansas City may see all types of severe storms, tornadoes, Saturday  KMBC Kansas City
4. Tornado threat continues after 4 injured, hundreds of homes damaged  Yahoo! Voices
5. Severe Threat though the weekend  KCRG

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Iowa weather: Tracking the potential for more severe weather Saturday - KCCI Des Moines

1. Iowa weather: Tracking the potential for more severe weather Saturday  KCCI Des Moines
2. Tornado Outbreak Expected Overnight In Plains, Midwest - Videos from The Weather Channel  The Weather Channel
3. Storm Track 3 Forecast: Tornado Watch, strong to severe storms expected  KSN-TV
4. Severe Threat though the weekend  KCRG
5. Dangerous tornado outbreak, flash flooding event expected Saturday as 55 million under severe weather threat  Fox Weather

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Updates: Oklahoma severe weather threat Saturday afternoon, evening - Oklahoman.com

1. Updates: Oklahoma severe weather threat Saturday afternoon, evening  Oklahoman.com
2. Dangerous tornado outbreak, flash flooding event expected Saturday as 55 million under severe weather threat  Fox Weather
3. Iowa weather: Tracking the potential for more severe weather Saturday  KCCI Des Moines
4. Plains Face Life-Threatening Tornadoes, Flooding | Weather.com  The Weather Channel
5. Kansas City may see all types of severe storms, tornadoes, Saturday  KMBC Kansas City

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Significant tornado and severe weather threat underway in the central US - CNN

1. Significant tornado and severe weather threat underway in the central US  CNN
2. Friday, Saturday to be peak days during dangerous central US severe weather outbreak  Yahoo! Voices
3. Kansas City tornado risk in severe thunderstorms Friday  KMBC Kansas City
4. The Daily Weather Update from FOX Weather: Multiday tornado threat across US underway  Fox Weather
5. Iowa weather: Severe threat returns to Des Moines  KCCI Des Moines

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April 26, 2024 at 12:07AM TECARTUS

For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).

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April 25, 2024 at 11:01PM YESCARTA

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

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April 25, 2024 at 07:50PM Combating Antibiotic Resistance

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

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Severe storm onslaught to unfold in the central US over the next 4 days - CNN

1. Severe storm onslaught to unfold in the central US over the next 4 days  CNN
2. Widespread Severe Storm Threat In Plains, Midwest | Weather.com  The Weather Channel
3. Severe Weather, Including a Tornado Risk, Is Forecast for the Central U.S.  The New York Times
4. Tornadoes, large hail, damaging winds possible Thursday as multiday severe weather threat begins in central US  Fox Weather
5. Multi-day Plains severe weather outbreak kicks off Thursday evening  The Washington Post

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April 25, 2024 at 06:07PM Clinical Guidances

This page lists Clinical Guidance documents.

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April 24, 2024 at 07:50PM Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

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April 24, 2024 at 05:08PM FDA CBER Webinar: Considerations for the Development of CAR T Cell Products - 03/07/2024

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, March 7 at 1:00 p.m.

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April 24, 2024 at 04:08PM Recently Issued Guidance Documents

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

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April 24, 2024 at 04:03PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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April 23, 2024 at 07:17PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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April 23, 2024 at 05:12PM eSubmitter Application History

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

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April 23, 2024 at 03:14PM Reflections on Travel to Europe – Part Three

I recently had the privilege of official travel to the European Union with our global affairs team.

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April 22, 2024 at 03:09PM Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

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April 22, 2024 at 03:03PM “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

Multiple layers of safeguards, including donor screening and testing, are used to reduce the riskof transmitting infection through blood transfusion.

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April 22, 2024 at 02:29PM Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans

Source Animal Product Preclinical, Clinical Issues, Xenotransplantation Products in Humans, Guidance for Industry, CBER, Biologics

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April 19, 2024 at 10:19PM FDA Roundup: April 19, 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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April 19, 2024 at 09:05PM Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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April 19, 2024 at 04:42PM Octaplas

Product approval information is indicated for Replacement of multiple coagulation factors in patients with acquired deficiencies
o due to liver disease
o undergoing cardiac surgery or liver transplant
Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP.

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April 19, 2024 at 04:19PM Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format

This is the Guidance for Industry, Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format, CBER, Biologics

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April 18, 2024 at 05:44PM OTP Events, Meetings, and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

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April 18, 2024 at 05:44PM OTP Town Hall: CMC Readiness for Gene Therapy BLAs - 06/04/2024

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Expe

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April 18, 2024 at 02:45PM Notifying FDA of Fatalities Related to Blood Collection or Transfusion

Notifying FDA of Fatalities Related to Blood Collection or Transfusion, CBER, biologics, guidance, industry, blood, transfusion, fatality, safety

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April 17, 2024 at 04:49PM 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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April 16, 2024 at 11:22PM ABECMA (idecabtagene vicleucel)

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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April 16, 2024 at 08:46PM Drugs@FDA Data Files

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

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April 16, 2024 at 04:10PM Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)

This is the CBER HCT/Ps Q&As- End of Compliance and Enforcement Policy main page with information for health care providers, clinics and regulated industry need to know about the end of FDA's compliance and enforcement policy, which ended on May 31, 2021 if they offer certain HCT/Ps.

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April 16, 2024 at 03:36PM Roster of the Blood Products Advisory Committee

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

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April 15, 2024 at 05:09PM Reflections on Travel to Europe – Part One

I recently had the privilege of official travel to the U.K. and European Union with our global affairs team.

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April 15, 2024 at 05:00PM General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations.

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April 12, 2024 at 02:16AM Statement on data accuracy issues with recently approved gene therapy

Statement by Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy

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April 12, 2024 at 12:28AM 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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April 11, 2024 at 03:28PM Development of Anti-Infective Drug Products for the Pediatric Population

Pediatric Drug Products

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April 11, 2024 at 12:09AM CBER 2024 Orphan Approvals (new BLAs)

CBER 2024 Orphan Approvals

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April 10, 2024 at 05:48PM eSubmitter Application History

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

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Millions across Gulf Coast face more severe weather, flooding, possible tornadoes - CBS News

1. Millions across Gulf Coast face more severe weather, flooding, possible tornadoes  CBS News
2. Possible tornado damage in Texas as severe weather outbreak, flash flooding unfolds across South  Fox Weather
3. Storms blast South with flooding and tornado threat: Live updates  CNN
4. SWLA school closures  KPLC
5. Powerful storm could bring severe conditions, power outages; forecast  USA TODAY

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April 10, 2024 at 02:35PM 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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April 09, 2024 at 09:30PM FDA Roundup: April 9, 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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Severe storms threaten flooding, tornadoes and large hail in South and parts of Mississippi Valley today - CNN

1. Severe storms threaten flooding, tornadoes and large hail in South and parts of Mississippi Valley today  CNN
2. Storms Threaten Millions With Severe Tornadoes, Hail And Flooding: Here's Where They Could Hit This Week  Forbes
3. Severe Storms Bring Tornado, Flood Threats To South | Weather.com  The Weather Channel
4. Multiday severe weather outbreak packing strong tornado threat could tear across South through Thursday  Fox Weather
5. Possibility of tornadoes in Baton Rouge on Wednesday | News  The Advocate

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April 08, 2024 at 03:03PM Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

This the Guidance for Industry, Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Level 1, CBER, CDER, Biologics, Drugs, December 2020

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April 05, 2024 at 05:10PM Vaccines Protect Children From Harmful Infectious Diseases

If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes the routinely administered vaccines for children and provides answers to commonly asked questions.

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April 09, 2024 at 12:20AM FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing - 02/29/2024

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, February 29 at 1:00 pm.

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April 08, 2024 at 05:34PM Providing Information about Pediatric Uses of Medical Devices

This guidance document describes how to compile and submit the readily available pediatric use information required under Section 515A of the FD&C Act.

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April 08, 2024 at 05:33PM Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff

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April 05, 2024 at 10:58PM Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

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April 03, 2024 at 09:34PM Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Pharmacology/Toxicology

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April 05, 2024 at 08:51PM FDA Roundup: April 5, 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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April 05, 2024 at 04:37PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.

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April 05, 2024 at 02:23PM Multilingual COVID-19 Resources

The U.S. Centers for Disease Control and Prevention (CDC), and international and U.S. Government partners including FDA, are addressing an outbreak of coronavirus disease 2019 (COVID-19).

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Satellite image shows cyclone storm sweeping across Michigan, southern states - MLive.com

1. Satellite image shows cyclone storm sweeping across Michigan, southern states  MLive.com
2. Deadly storms and tornadoes leave a path of destruction from Georgia to Illinois  CNN
3. Tornadoes Confirmed Amid Severe Weather Outbreak | Weather.com  The Weather Channel
4. News Wrap: Storm system brings tornadoes to South and Midwest, snow to New England  PBS NewsHour
5. Tornado threat in Ohio; tracking severe weather  10TV

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Satellite image shows cyclone storm sweeping across Michigan, southern states - MLive.com

1. Satellite image shows cyclone storm sweeping across Michigan, southern states  MLive.com
2. Deadly storms and tornadoes leave a path of destruction from Georgia to Illinois  CNN
3. Tornadoes Confirmed Amid Severe Weather Outbreak | Weather.com  The Weather Channel
4. Gov. Justice declares State of Emergency in Fayette, Kanawha, Lincoln, and Nicholas Counties  Governor Jim Justice
5. Severe storms rip across United States with tornadoes, power outages  USA TODAY

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Satellite image shows cyclone storm sweeping across Michigan, southern states - MLive.com

1. Satellite image shows cyclone storm sweeping across Michigan, southern states  MLive.com
2. Deadly storms and tornadoes leave a path of destruction from Georgia to Illinois  CNN
3. Tornadoes Confirmed Amid Severe Weather Outbreak | Weather.com  The Weather Channel
4. Millions still under tornado watches as severe storms batter Midwest, Southeast  CBS News
5. Severe storms rip across United States with tornadoes, power outages  USA TODAY

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Deadly storms and tornadoes leave a path of destruction from Georgia to Illinois - CNN

1. Deadly storms and tornadoes leave a path of destruction from Georgia to Illinois  CNN
2. Satellite image shows cyclone storm sweeping across Michigan, southern states  MLive.com
3. Tornadoes Confirmed Amid Severe Weather Outbreak | Weather.com  The Weather Channel
4. Ohio sees record tornado activity so far in 2024. Will it continue?  The Columbus Dispatch
5. Storms bring tornadoes to Midwest  CBS News

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Severe storms hit Ohio, Kentucky, Tennessee with tornadoes, high winds - Axios

1. Severe storms hit Ohio, Kentucky, Tennessee with tornadoes, high winds  Axios
2. Potential Outbreak Of Tornadoes, Hail, Wind Ahead Today - Videos from The Weather Channel  The Weather Channel
3. More than 275,000 power outages reported in Ohio Valley after storms brought damaging winds, dangerous hail and tornadoes  CNN
4. New Nighttime Tornado Watches  WSAZ
5. Traffic reopens on I-75 near Monroe after power lines knocked down in storms  WLWT Cincinnati

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Weather updates: Severe weather in Charleston WV | Kanawha Valley - Charleston Gazette-Mail

1. Weather updates: Severe weather in Charleston WV | Kanawha Valley  Charleston Gazette-Mail
2. Severe storms damage homes, cut off power to thousands of Americans across Ohio Valley  CNN
3. Severe weather outbreak produces tornadoes, damage from Ohio Valley to Southeast  Fox Weather
4. Severe storm threatens parts of US with hail, tornadoes, power outages  USA TODAY
5. Traffic reopens on I-75 near Monroe after power lines knocked down in storms  WLWT Cincinnati

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April 03, 2024 at 01:14AM 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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April 03, 2024 at 01:03AM FDA Warns About Stem Cell Therapies

Stem cells have been called everything from cure-alls to miracle treatments. But don't believe the hype. The U.S. Food and Drug Administration is concerned that some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. Here's what to know before you consider s

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Severe spring storm threatens parts of US with possible tornados: Live updates - The Independent

1. Severe spring storm threatens parts of US with possible tornados: Live updates  The Independent
2. Potential Outbreak Of Tornadoes, Hail, Wind Ahead Today - Videos from The Weather Channel  The Weather Channel
3. Severe storms to snowflakes; colder changes on the way!  FOX 59 Indianapolis
4. LIVE UPDATES: Threat for significant severe weather Tuesday; tornadoes, hail possible  WLWT Cincinnati
5. Significant tornado threat and potential severe weather outbreak target parts of Ohio Valley and South  Yahoo! Voices

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Ongoing severe weather outbreak continues Tuesday with strong, long-track tornado threat in Ohio Valley - Fox Weather

1. Ongoing severe weather outbreak continues Tuesday with strong, long-track tornado threat in Ohio Valley  Fox Weather
2. Potential Outbreak Of Tornadoes, Hail, Wind Ahead Today - Videos from The Weather Channel  The Weather Channel
3. Significant tornado threat and potential severe weather outbreak target parts of Ohio Valley and South  CNN
4. LIVE UPDATES: Threat for significant severe weather Tuesday; tornadoes, hail possible  WLWT Cincinnati
5. Tornado warnings, watches Tuesday in Louisville region  WLKY Louisville

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Columbus Weather: Tuesday begins with rain; hail, winds, possible tornadoes this afternoon - ABC6OnYourSide.com

1. Columbus Weather: Tuesday begins with rain; hail, winds, possible tornadoes this afternoon  ABC6OnYourSide.com
2. Potential Outbreak Of Tornadoes, Hail, Wind Ahead Today - Videos from The Weather Channel  The Weather Channel
3. Severe storms could bring tornadoes and golf-ball-sized hail to parts of Southeast and Ohio Valley  CNN
4. Tracking central Ohio severe weather  10TV
5. Ongoing severe weather outbreak continues Tuesday with strong, long-track tornado threat in Ohio Valley  Fox Weather

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April 01, 2024 at 11:48PM 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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April 01, 2024 at 05:02PM 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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April 01, 2024 at 04:47PM Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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March 29, 2024 at 02:04PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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April 01, 2024 at 07:48AM MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

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