July 01 2023 at 03:55AM Test Article 6/30/23 Draft 1.1

Test Article 6/30/23

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June 30 2023 at 09:21PM OTP Events Meetings and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

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June 30 2023 at 08:29PM FDA Roundup: June 30 2023

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

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June 30 2023 at 08:26PM 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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June 30 2023 at 07:26PM ROCTAVIAN

Product information for ROCTAVIAN

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June 30 2023 at 06:43PM 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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June 30 2023 at 12:01AM FDA Approves First Gene Therapy for Adults with Severe Hemophilia A

FDA approves Roctavian, the first adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A.

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June 29 2023 at 09:29PM 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.


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June 27 2023 at 11:24PM Know Your Treatment Options for COVID-19

Patients today have more treatment options in the battle against COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.

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June 29 2023 at 02:45PM Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment

Clinical / Medical

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June 28 2023 at 11:58PM FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

The FDA approved Lantidra, the first cellular therapy for the treatment of adults with type 1 diabetes who are unable to approach average blood glucose levels because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.

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June 28 2023 at 10:43PM Principal Investigator: Molecular Biologist with Bioinformatics experience

The FDA’s Center for Biologics Evaluation and Research, Office of Blood Research and Review, Division of Emerging and Transfusion Transmitted Diseases is recruiting to fill a Senior Staff Fellow/Visiting Scientist position to serve as a Principal Investigator in the Laboratory of Emerging Pathogens.

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June 28 2023 at 08:10PM Devices Guidances

This page lists Medical Device Guidance documents.

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June 28 2023 at 07:25PM BK220791 - e-Delphyn Donor

The e-Delphyn Donor is a web enabled modular computerized system intended to be used by trained personnel to aid in donor management.

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June 28 2023 at 06:46PM Marketing Category

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

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June 27 2023 at 10:11PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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June 27 2023 at 09:11PM FDA Roundup: June 27 2023

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

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June 27 2023 at 05:18PM Towards Longer-Acting Factor VIII Products with Better Purity

A description of Andrey Sarafanov's research program and related publications.

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June 27 2023 at 02:49PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023

This is the list of guidance topics CBER is considering for development during Calendar Year 2023 - UpdatedJune 2023

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June 27 2023 at 02:41PM BK220798 - NexSys PCS Plasma Collection System with ExpressPlus Technology

The NexSys PCS® plasma collection system with Express®Plus Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation.

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June 27 2023 at 02:10PM EUCYT Laboratories LLC - 607182 - 06/04/2020

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

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June 26 2023 at 03:46PM Montgomery Women's Medical Center PC dba Montgomery Fertility Center - 607345 - 05/14/2020

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

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June 26 2023 at 03:30PM North Coast Biologics - 607532 - 05/21/2020

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

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June 26 2023 at 02:50PM BK230820 - Erytra Eflexis

Erytra Eflexis is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests.


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Frozen fruit recall: Products sold at Aldi Target and Trader possible for listeria - Detroit Free Press

1. Frozen fruit recall: Products sold at Aldi, Target and Trader possible for listeria  Detroit Free Press
2. Frozen fruit recalled due to possible listeria outbreak. What to know about the foodborne illness.  Yahoo Life
3. Massive frozen fruit recall includes Walmart, Target, Trader Joe's, Aldi, Whole Foods  WBNS 10TV
4. Distributor issues recall of frozen fruit sold in Kentucky. Check for these lot codes  Lexington Herald Leader
5. Frozen fruit sold at Trader Joe's recalled for possible listeria  SFGATE

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Frozen fruit recall due to possible Listeria contamination - WRAL News

1. Frozen fruit recall due to possible Listeria contamination  WRAL News
2. Frozen fruit recalled due to possible listeria outbreak. What to know about the foodborne illness.  Yahoo Life
3. Massive frozen fruit recall includes Walmart, Target, Trader Joe's, Aldi, Whole Foods  WBNS 10TV
4. Distributor issues recall of frozen fruit sold in Kentucky. Check for these lot codes  Lexington Herald Leader
5. FDA announces recall for frozen fruit sold in Indiana  WISH TV Indianapolis, IN
6. View Full Coverage on Google News

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More frozen fruit recalled over Listeria concerns - Food Safety News

1. More frozen fruit recalled over Listeria concerns  Food Safety News
2. Frozen fruit recalled due to possible listeria outbreak. What to know about the foodborne illness.  Yahoo Life
3. Massive frozen fruit recall includes Walmart, Target, Trader Joe's, Aldi, Whole Foods  WBNS 10TV
4. FDA announces recall for frozen fruit sold in Indiana  WISH TV Indianapolis, IN
5. Frozen fruit sold at Walmart, Aldi, Trader Joe's, Target, Whole Foods recalled over possible listeri  WFAA
6. View Full Coverage on Google News

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Frozen fruit recall due to possible Listeria contamination - WRAL News

1. Frozen fruit recall due to possible Listeria contamination  WRAL News
2. Frozen fruit recalled due to possible listeria outbreak. What to know about the foodborne illness.  Yahoo Life
3. Massive frozen fruit recall includes Walmart, Target, Trader Joe's, Aldi, Whole Foods  WBNS 10TV
4. FDA announces recall for frozen fruit sold in Indiana  WISH TV Indianapolis, IN
5. Frozen fruit sold at Walmart, Aldi, Trader Joe's, Target, Whole Foods recalled over possible listeri  WFAA
6. View Full Coverage on Google News

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Frozen fruit recall: Products sold at Walmart Target pose listeria risk - MarketWatch

1. Frozen fruit recall: Products sold at Walmart, Target pose listeria risk  MarketWatch
2. Frozen fruit recalled due to possible listeria outbreak. What to know about the foodborne illness.  Yahoo Life
3. Frozen fruit recalled due to possible listeria contamination  CBS Evening News
4. FDA announces recall for frozen fruit sold in Indiana  WISH TV Indianapolis, IN
5. Massive frozen fruit recall includes Walmart, Target, Trader Joe's, Aldi, Whole Foods  WBNS 10TV
6. View Full Coverage on Google News

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June 23 2023 at 02:32PM Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical

This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.

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June 22 2023 at 10:57PM Consumer Updates

Science-based health and safety information you can trust.

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June 22 2023 at 08:04PM FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

FDA Approves Elevidys, a gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing reason why they cannot receive this therapy.

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June 21 2023 at 09:30PM 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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June 20 2023 at 07:33PM 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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June 20 2023 at 10:40PM IDELVION

Product approval information is indicated for children and adults with hemophilia B (congenital Factor IX deficiency) for 1) On-demand control and prevention of bleeding episodes; 2) Perioperative management of bleeding; 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

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June 20 2023 at 09:35PM FDA Roundup: June 20 2023

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

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June 20 2023 at 08:39PM Drugs@FDA Data Files

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

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Russian Army Hit by Cholera Outbreak After Kakhovka Dam Flooding - Newsweek

1. Russian Army Hit by Cholera Outbreak After Kakhovka Dam Flooding  Newsweek
2. Kakhovka collapse: image emerges of apparently explosive-laden car at dam  The Guardian
3. Ukraine's mammoth cleanup two weeks after the Nova Kakhovka dam collapse | The World  ABC News (Australia)
4. Four of Putin's attack helicopters downed in last week, Kyiv says  The Independent
5. Inside a Ukrainian village destroyed by Kakhovka dam floods  The Times and The Sunday Times
6. View Full Coverage on Google News

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June 20 2023 at 03:29PM Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Clinical Pharmacology

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Ukraine updates: Dam collapse a Russian 'inside job' - DW (English)

1. Ukraine updates: Dam collapse a Russian 'inside job'  DW (English)
2. Ukrainian dam collapsed due to controlled explosion: report  Business Insider
3. Evidence suggests Russia blew Kakhovka dam in Ukraine: NYT  Reuters.com
4. Evidence is growing that Russia blew up Kakhovka Dam: Ukraine live updates  USA TODAY
5. Russian units in Kherson Oblast and Crimea, stricken in cholera outbreak, ‘losing combat effectiveness’  Yahoo News
6. View Full Coverage on Google News

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Ukraine updates: Dam collapse a Russian 'inside job' - DW (English)

1. Ukraine updates: Dam collapse a Russian 'inside job'  DW (English)
2. Russia likely behind Ukraine dam collapse, experts say  Reuters
3. Russian units in Kherson Oblast and Crimea, stricken in cholera outbreak, ‘losing combat effectiveness’  Yahoo News
4. Evidence Suggests Russia Blew Up Kakhovka Dam In Ukraine, New York Times Reports  Radio Free Europe / Radio Liberty
5. Evidence suggests Russia blew Kakhovka dam in Ukraine - New York Times  Reuters
6. View Full Coverage on Google News

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Death toll rises from flooding after Ukraine dam breach - Reuters

1. Death toll rises from flooding after Ukraine dam breach  Reuters
2. Ukraine Situation Report: Waning Flood Waters Could Provide Opportunity For Kyiv's Forces  Yahoo News
3. As Floodwaters Recede, Ukrainian Authorities Brace for Possible Disease Outbreaks  The New York Times
4. Russia likely behind Ukraine dam collapse, experts say  Reuters
5. Ukraine: Risks Of The Dnipro's Falling Water Levels  Barron's
6. View Full Coverage on Google News

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At least 16 dead in Kakhovka dam collapse flooding Kyiv says - CNN

1. At least 16 dead in Kakhovka dam collapse flooding, Kyiv says  CNN
2. Russia likely behind Ukraine dam collapse, experts say  Reuters
3. Death toll rises from flooding after Ukraine dam breach  Bangkok Post
4. Ukraine Situation Report: Waning Flood Waters Could Provide Opportunity For Kyiv's Forces  Yahoo News
5. As Floodwaters Recede, Ukrainian Authorities Brace for Possible Disease Outbreaks  The New York Times
6. View Full Coverage on Google News

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Russian snipers fire on boats transporting Ukrainians from flooded towns - New York Post

1. Russian snipers fire on boats transporting Ukrainians from flooded towns  New York Post
2. Russia likely behind Ukraine dam collapse, experts say  Reuters
3. Russian units in Kherson Oblast and Crimea, stricken in cholera outbreak, ‘losing combat effectiveness’  Yahoo News
4. As Floodwaters Recede, Ukrainian Authorities Brace for Possible Disease Outbreaks  The New York Times
5. At least 16 dead in Kakhovka dam collapse flooding, Kyiv says  CNN
6. View Full Coverage on Google News

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At least 16 dead in Kakhovka dam collapse flooding Kyiv says - CNN

1. At least 16 dead in Kakhovka dam collapse flooding, Kyiv says  CNN
2. Russia likely behind Ukraine dam collapse, experts say  Reuters
3. As Floodwaters Recede, Ukrainian Authorities Brace for Possible Disease Outbreaks  The New York Times
4. Photos reveal drastic changes to Kakhovka Reservoir as water levels drop  Yahoo News
5. Rescuers are braving snipers as they rush to ferry Ukrainians from Russia-occupied flood zones  The Associated Press
6. View Full Coverage on Google News

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Severe storms forecast in Oklahoma Kansas and Texas NWS says - USA TODAY

1. Severe storms forecast in Oklahoma, Kansas and Texas, NWS says  USA TODAY
2. Storms knock out power to more than 100,000 across the South with high winds and at least 8 reported tornadoes  Yahoo! Voices
3. Doppler 10 Live Update: Tracking threat of severe storms  WBNS 10TV
4. Oklahoma City, Dallas under Tornado Watch as severe storms march through southern Plains  Fox Weather
5. Severe weather outbreak leaves path of destruction across the South  ABC11
6. View Full Coverage on Google News

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June 15 2023 at 08:07PM Industry (Biologics)

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

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Renewed significant severe weather event threatens nearly 20 million across Plains Southeast Thursday - Fox Weather

1. Renewed ‘significant severe weather event’ threatens nearly 20 million across Plains, Southeast Thursday  Fox Weather
2. Severe weather outbreak leaves path of destruction across the South  ABC11
3. Tornado watches issued in South as severe weather outbreak continues: Latest  ABC News
4. Severe storms forecast in Oklahoma, Kansas and Texas, NWS says  USA TODAY
5. Severe weather expected from Colorado to South Carolina  CNN
6. View Full Coverage on Google News

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Severe storms forecast in Oklahoma Kansas and Texas NWS says - USA TODAY

1. Severe storms forecast in Oklahoma, Kansas and Texas, NWS says  USA TODAY
2. Why Today's Severe Threat Is So Rare - Videos from The Weather Channel  The Weather Channel
3. Severe weather outbreak leaves path of destruction across the South  ABC11
4. Severe weather expected from Colorado to South Carolina  CNN
5. Renewed 'Significant Severe Weather Event' Threatens Nearly 20 Million Across Plains, Southeast  FOX Weather
6. View Full Coverage on Google News

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June 15 2023 at 06:32PM Roster of the Blood Products Advisory Committee

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

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June 15 2023 at 04:45PM BOOSTRIX

Boostrix is a product approval indicated for Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 years of age and older

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Punishing winds possible tornadoes inflict damage as storms cross US South - The Associated Press

1. Punishing winds, possible tornadoes inflict damage as storms cross US South  The Associated Press
2. Severe weather strikes the South with tornadoes, hail l WNT  ABC News
3. Multiple reports of tornadoes as rare June severe weather outbreak hits Southeast  NBC News
4. Tornadoes cause damage in Alabama, Georgia  CBS Evening News
5. See the tornadoes, massive hail leaving destruction across the Southeast as severe weather outbreak continues  Fox Weather
6. View Full Coverage on Google News

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Multiple tornadoes reported as severe weather outbreak hits Alabama Georgia - USA TODAY

1. Multiple tornadoes reported as severe weather outbreak hits Alabama, Georgia  USA TODAY
2. Why Today's Severe Threat Is So Rare - Videos from The Weather Channel  The Weather Channel
3. Significant Threat For Strong Tornadoes, 80+ mph Wind Gusts, Large Hail Expected For Southeast  FOX Weather
4. Strong storms could pop up in the Hill Country area  KVUE.com
5. Weather Impact Day issued for Wednesday late afternoon, evening  WAPT Jackson

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Tornadoes and 'very large hail' threaten southern US - BBC

1. Tornadoes and 'very large hail' threaten southern US  BBC
2. Severe Weather Outbreak Expected Into Wednesday Night - Videos from The Weather Channel  The Weather Channel
3. Significant Threat For Strong Tornadoes, 80+ mph Wind Gusts, Large Hail Expected For Southeast  FOX Weather
4. Strong storms could pop up in the Hill Country area  KVUE.com
5. Unusual Deep South June Severe Weather Outbreak Expected  The Weather Channel
6. View Full Coverage on Google News

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Tornadoes reported as rare June severe weather outbreak hits Southeast - NBC News

1. Tornadoes reported as rare June severe weather outbreak hits Southeast  NBC News
2. Unusual Deep South June Severe Weather Outbreak Expected With Derecho Possible  The Weather Channel
3. Significant Threat For Strong Tornadoes, 80+ mph Wind Gusts, Large Hail Expected For Southeast  FOX Weather
4. Millions across the South and Northeast could face severe weather today  CNN
5. Dallas weather: Storms for some on Wednesday, triple-digit heat coming soon  FOX 4 News Dallas-Fort Worth
6. View Full Coverage on Google News

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June 14 2023 at 06:44PM Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - 04/27/2023

Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

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June 13 2023 at 08:09PM 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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June 13 2023 at 09:22PM FDA Roundup: June 13 2023

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

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June 13, 2023 at 08:02PM Reproductive Technologies, Inc. - 594292 - 11/06/2019

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

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June 13, 2023 at 08:01PM Reproductive Technologies, Inc. - 594292 - 12/03/2021

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

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Chris Christie claims 'Voldemort' Trump wanted to pin Covid outbreak on him – live - The Independent

1. Chris Christie claims 'Voldemort' Trump wanted to pin Covid outbreak on him – live  The Independent
2. Takeaways from CNN’s town hall with Chris Christie  CNN
3. 'Three-time loser.' Christie rips Trump, makes case for 2024 in town hall: 7 takeaways.  USA TODAY
4. Chris Christie won't win the GOP prez nomination. But he can serve a good purpose | Dick Polman  Pennsylvania Capital-Star
5. Live updates: Chris Christie town hall on CNN  CNN
6. View Full Coverage on Google News

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June 13, 2023 at 03:21PM VYJUVEK

Indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

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June 13, 2023 at 02:56PM Content of Premarket Submissions for Device Software Functions

The guidance describes FDA’s thinking on recommended documentation included in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions.

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June 12, 2023 at 10:16PM AFSTYLA

AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes,
• Routine prophylaxis to reduce the frequency of bleeding episodes,
• Perioperative management of bleeding.

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June 12, 2023 at 10:04PM Antimicrobial Resistance Information from FDA

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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June 12, 2023 at 03:31PM PREA Non-Compliance Letters

PREA Non-Compliance Letters

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June 12, 2023 at 03:07PM 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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June 12, 2023 at 02:57PM Regenerative Medicine Fellowship under the Service Fellowship Program for CBER

Regenerative medicine is an interdisciplinary field, which aims to repair diseased or damaged tissues using biological or cell-based technologies. This rapidly growing area of biomedical research encompasses cell biology, tissue engineering, drug delivery, and advanced manufacturing, among others.

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June 12, 2023 at 01:46PM Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials.

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June 09, 2023 at 09:27PM FDA Roundup: June 9, 2023

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

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June 09, 2023 at 07:24PM Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement - 05/18/2023

This is the main landing page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 18, 2023 Meeting announcement and meeting materials.

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June 09, 2023 at 06:11PM CBER-Regulated Products: Shortages and Discontinuations

A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

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June 06, 2023 at 05:54PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

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June 06, 2023 at 05:52PM Blood Products Advisory Committee April 26, 2023 Meeting Announcement - 04/26/2023

This is the main page for the Blood Products Advisory Committee April 26, 2023 Meeting Announcement and meeting materials.

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June 05, 2023 at 03:02PM 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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June 05, 2023 at 02:22PM Antimicrobial Resistance Information from FDA

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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June 02, 2023 at 09:45PM FDA Roundup: June 2, 2023

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

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June 02, 2023 at 08:16PM Clinical Guidances

This page lists Clinical Guidance documents.

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June 02, 2023 at 06:38PM Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement - 05/18/2023

This is the main landing page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 18, 2023 Meeting announcement and meeting materials.

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June 02, 2023 at 06:32PM Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023

This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials.

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June 02, 2023 at 02:00PM Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Clinical Pharmacology

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May 31, 2023 at 07:50PM Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

This guidance describes the mechanisms available through which submitters can request FDA feedback regarding potential or planned medical device submissions.

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June 02, 2023 at 12:14AM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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June 01, 2023 at 07:14PM Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials.

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June 01, 2023 at 06:38PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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June 01, 2023 at 05:16AM 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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June 01, 2023 at 04:45PM Consumer Updates

Science-based health and safety information you can trust.

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June 01, 2023 at 12:55PM FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes - 05/16/2023

FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes. Virtual 2-day free public workshop.

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