October 31, 2022 at 10:05PM Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

Predicting Stem Cell Activity to Ensure Safe and Effective Therapies

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October 31, 2022 at 09:54PM FluLaval

Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.

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China braces for wave of workers fleeing iPhone factory in Covid-hit Zhengzhou - The Guardian

1. China braces for wave of workers fleeing iPhone factory in Covid-hit Zhengzhou  The Guardian
2. Apple: Chinese workers flee Covid lockdown at iPhone factory  BBC
3. Chinese cities brace for wave of Foxconn workers from COVID-hit Zhengzhou  Reuters
4. China Ramps Up Covid Lockdowns; Workers Leave IPhone Plant  Bloomberg Markets and Finance
5. COVID-19 outbreak at Foxconn's largest factory in China sends workers fleeing: reports  Fox Business

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Workers flee China's Covid restrictions at Foxconn's huge iPhone factory - Financial Times

1. Workers flee China's Covid restrictions at Foxconn's huge iPhone factory  Financial Times
2. Chinese cities brace for wave of Foxconn workers from COVID-hit Zhengzhou  Reuters
3. China braces for wave of workers fleeing iPhone factory in Covid-hit Zhengzhou  The Guardian
4. Workers leave iPhone factory in Zhengzhou amid COVID curbs  The Washington Post
5. China’s biggest iPhone factory acts after workers flee Covid-19 outbreak  South China Morning Post

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October 25, 2022 at 08:16PM FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

The FDA approved Boostrix for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

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October 28, 2022 at 12:06AM 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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October 27, 2022 at 11:30PM 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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October 26, 2022 at 08:08PM Consumer Updates

Science-based health and safety information you can trust.

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October 21, 2022 at 03:14PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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October 26, 2022 at 01:58AM 2022_10 Test Article EDITED FT 02

2022_10 Test - Please Ignore.

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October 25, 2022 at 09:31PM Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting

Summary of published article

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October 25, 2022 at 09:18PM FDA model suggests that a hepatitis C vaccine could reduce transmission of the virus among injecting drug users

Summary of published research article for posting on Innovation website (research summaries section)

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October 21, 2022 at 03:31PM 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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October 24, 2022 at 10:22PM Pentacel

For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).

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Nearly half of Virginia high school out sick due to flu-like, gastrointestinal symptoms in mystery outbreak - NBC News

1. Nearly half of Virginia high school out sick due to flu-like, gastrointestinal symptoms in mystery outbreak  NBC News
2. Virginia high school reports illness outbreak, 1,000 students call out sick  Fox News
3. Stafford High School open Monday after illness outbreak leaves 1000 students out sick | FOX 5 DC  FOX 5 Washington DC
4. About 1,000 students out sick with flu symptoms at Virginia high school  New York Post
5. Nearly Half Of Virginia High School Out Sick With Flu-Like Illness  NBC News
6. View Full Coverage on Google News

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October 21, 2022 at 09:58PM FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - 11/15/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapy.

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October 21, 2022 at 03:16PM Human Gene Therapy for Neurodegenerative Diseases

This is the final guidance for industry, Human Gene Therapy for Neurodegenerative Diseases.

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October 21, 2022 at 03:14PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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October 21, 2022 at 01:57PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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October 20, 2022 at 10:25PM Investigational COVID-19 Convalescent Plasma

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.


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October 19, 2022 at 08:31PM Clinical Investigator Inspection List Q-S

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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October 19, 2022 at 05:15PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) 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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October 19, 2022 at 04:06PM 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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October 19, 2022 at 03:24PM 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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October 19, 2022 at 08:47PM Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

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October 17, 2022 at 09:25PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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October 18, 2022 at 05:14PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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October 18, 2022 at 09:17PM Roster of the Blood Products Advisory Committee

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

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October 18, 2022 at 09:05PM Valley Biosystems - 632553 - 10/14/2022

Bioresearch Monitoring Program

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October 18, 2022 at 09:02PM Valley Biosystems - 632553 - 08/03/2022

Bioresearch Monitoring Program


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October 18, 2022 at 02:14PM 2022 Meeting Materials, Blood Products Advisory Committee

This is the main page for the CBER 2022 Meeting Materials, Blood Products Advisory Committee.

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October 18, 2022 at 02:14PM Meeting Materials, Blood Products Advisory Committee

This is the Meeting Materials, Blood Products Advisory Committee main landing page

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October 17, 2022 at 10:23PM FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk

The FDA has recently received inquiries regarding the presence of human papillomavirus (HPV) DNA fragments in Gardasil and is aware that information related to this issue is on the internet. A concern that the presence of these fragments could represent contamination of the vaccine arises from an unpublished report that recombinant HPV L1-specific DNA sequences were present in 13 vials of Gardasil from different lots.

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October 17, 2022 at 10:19PM Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

List of Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed products

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October 17, 2022 at 10:18PM Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

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October 17, 2022 at 09:13PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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October 14, 2022 at 07:58PM FDA's Critical Role in Ensuring Supply of Influenza Vaccine

The flu vaccine you get is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts. Sound complicated? It is. The FDA and HHS are working on developing new and better technologies for producing flu vaccines.

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October 17, 2022 at 01:07PM 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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Emmanuel the Emu Sick After Wild Geese, Bird Flu Strike Florida Farm - TMZ

1. Emmanuel the Emu Sick After Wild Geese, Bird Flu Strike Florida Farm  TMZ
2. TikTok Star Emmanuel the Emu Sickened in Deadly Flu Outbreak  Yahoo! Voices
3. View Full Coverage on Google News

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Emmanuel the Emu Sick After Wild Geese, Bird Flu Strike Florida Farm - TMZ

1. Emmanuel the Emu Sick After Wild Geese, Bird Flu Strike Florida Farm  TMZ
2. TikTok Star Emmanuel the Emu Sickened in Deadly Flu Outbreak  Yahoo! Voices

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October 14, 2022 at 04:34PM FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing

FDA is keenly interested in these technologies because they could potentially provide flexibility for drug manufacturers to enable rapid and localized response to changing demand and increase timely access to quality drugs for U.S. patients.

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October 14, 2022 at 04:23PM Investigational New Drug Applications (INDs) for CBER-Regulated Products

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

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October 13, 2022 at 07:08PM Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement - 09/22/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement.

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October 13, 2022 at 04:41PM 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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October 13, 2022 at 04:12PM 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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October 13, 2022 at 02:43PM It’s a Good Time to Get Your Flu Vaccine

Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

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October 12, 2022 at 11:57PM 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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October 12, 2022 at 09:25PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

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October 12, 2022 at 03:58PM COVID-19 Bivalent Vaccine Boosters

A single booster dose with an updated bivalent COVID-19 vaccine provides broad protection against COVID-19 and is expected to provide better protection against COVID-19 caused by the currently circulating Omicron variant.

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October 12, 2022 at 03:41PM Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.

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October 11, 2022 at 06:14PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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October 11, 2022 at 04:11PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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October 07, 2022 at 09:32PM 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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Box Office Upset: ‘Smile’ Bites Off Big $17.6M as ‘Amsterdam’ Bombs and ‘Lyle, Lyle, Crocodile’ Limps - Hollywood Reporter

1. Box Office Upset: ‘Smile’ Bites Off Big $17.6M as ‘Amsterdam’ Bombs and ‘Lyle, Lyle, Crocodile’ Limps  Hollywood Reporter
2. The box office can't crack this 'Smile'  New York Post
3. Is There a 'Smile' Movie End Credits Scene? Details Revealed!  Just Jared
4. Box Office: ‘Smile’ Beats ‘Lyle Lyle Crocodile’ as David O. Russell’s ‘Amsterdam’ Flops  Variety
5. 'Smile' Director: Star Sosie Bacon Really Did Her Homework  Hollywood Outbreak
6. View Full Coverage on Google News

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October 07, 2022 at 11:28PM Respuesta de la FDA a la viruela del mono

Respuesta de la FDA a la viruela del mono

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October 07, 2022 at 09:03PM FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

The FDA approved Boostrix for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

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October 07, 2022 at 01:56AM 2022_10 Test Article EDITED FT 01

2022_10 Test Article DD

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U.S. to redirect flights from Uganda to five airports for Ebola screening - The Washington Post

1. U.S. to redirect flights from Uganda to five airports for Ebola screening  The Washington Post
2. U.S. to Begin Screening Air Passengers From Uganda for Ebola  The New York Times
3. Airline passengers arriving to the US from Uganda will be routed through five airports for Ebola screening  CNN
4. U.S. Orders Air Travelers From Uganda Screened for Ebola  The Wall Street Journal
5. Ebola virus outbreak prompts Uganda to host regional meeting with CDC and WHO  NBC News

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October 06, 2022 at 05:32PM FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

FDA is modernizing the agency’s oversight of clinical research and harmonizing with the U.S. Department of Health and Human Service Common Rule to make clinical trials more efficient and improve information for potential participants.

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October 03, 2022 at 07:18PM User Fees and Refunds for Premarket Notification Submissions (510(k)s)

This guidance identifies the types of 510(k)s subject to user fees, exceptions to user fees, and the actions that may result in user fee refunds.

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October 05, 2022 at 04:40PM 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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October 05, 2022 at 04:05PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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October 04, 2022 at 10:14PM Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

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October 04, 2022 at 08:57PM Cervarix

Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females9 through 25 years of age.

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October 04, 2022 at 08:40PM CBER Vaccine ICSR (Legacy) Implementation

In support of the “Postmarketing Safety Reporting for Combination Products” rule, FDA is proposing to update VAERS Electronic Reporting Resource

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October 04, 2022 at 07:57PM BEXSERO

Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

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October 03, 2022 at 11:25PM Medical Device Accessories - Describing Accessories and Classification Pathways

Provide guidance to about the regulation of accessories to medical devices. Intended to describe policy concerning the classification of accessories and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices.

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October 03, 2022 at 04:03PM FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals

Describes FDA actions that may be taken on 510(k)s, effect actions have on goals under MDUFA III and MDUFA IV, industry actions that may be taken on 510(k)s.

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October 03, 2022 at 04:02PM FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - 11/15/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapy.

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October 03, 2022 at 02:33PM 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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Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria - WDIV ClickOnDetroit

1. Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria  WDIV ClickOnDetroit
2. Listeria outbreak leads to recall of cheeses sold at a dozen retailers  CNN
3. CDC warns of listeria outbreak  Good Morning America
4. Possible listeria outbreak leads to recall of cheeses found on CNY store shelves  syracuse.com
5. CDC issues listeria alert | What to know  11Alive

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Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria - WDIV ClickOnDetroit

1. Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria  WDIV ClickOnDetroit
2. Listeria outbreak leads to recall of cheeses sold at a dozen retailers  CNN
3. CDC warns of listeria outbreak  Good Morning America
4. Possible listeria outbreak leads to recall of cheeses found on CNY store shelves  syracuse.com
5. CDC issues listeria alert | What to know  11Alive
6. View Full Coverage on Google News

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Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria - WDIV ClickOnDetroit

1. Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria  WDIV ClickOnDetroit
2. Listeria outbreak leads to recall of cheeses sold at a dozen retailers  CNN
3. CDC warns of listeria outbreak  Good Morning America
4. Listeria outbreak linked to more than 20 brands of brie and camembert cheese leads to recall  WPVI-TV
5. CDC issues listeria alert | What to know  11Alive

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Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria - WDIV ClickOnDetroit

1. Michigan cheeses sold at Meijer, Whole Foods, other stores recalled for possible Listeria  WDIV ClickOnDetroit
2. Listeria outbreak leads to recall of cheeses sold at a dozen retailers  CNN
3. CDC issues alert about listeria outbreak linked to brie, camembert  CBS New York
4. Dozens of brie, camembert products recalled amid listeria outbreak  ABC News
5. CDC warns of listeria outbreak  Good Morning America
6. View Full Coverage on Google News

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