June 24, 2024 at 04:13PM Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

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June 28, 2024 at 08:36PM Administrative Guidances

This page lists Administrative Guidance documents.

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June 28, 2024 at 02:55PM Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

To facilitate and streamline development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological products, by improving the consistency of drug delivery performance information developed and included in applications.

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June 27, 2024 at 09:26PM KYMRIAH

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

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June 27, 2024 at 06:56PM FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program

FDA is taking steps to help accelerate the development of novel drugs and biologics through the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. Learn more.

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June 27, 2024 at 04:19PM The Concerning Trend in Men’s Health

Despite spending more on healthcare than any other nation on earth, life expectancy in the U.S. is trending downward.

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June 26, 2024 at 08:36PM Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

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June 25, 2024 at 09:34PM Recently Issued Guidance Documents

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

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June 25, 2024 at 07:43PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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June 25, 2024 at 03:20PM 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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June 24, 2024 at 08:22PM Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024

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

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June 24, 2024 at 04:10PM 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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June 24, 2024 at 04:02PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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June 24, 2024 at 03:01PM Laboratory Developed Tests: Small Entity Compliance Guide

FDA has prepared this document to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.


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June 20, 2024 at 05:22PM 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 20, 2024 at 11:24PM FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy

The FDA expanded the approval of Elevidys, a gene therapy for the treatment of Duchenne muscular dystrophy for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.

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June 20, 2024 at 11:07PM International Activities

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

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June 20, 2024 at 06:20PM TRUMENBA

Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

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June 20, 2024 at 05:37PM Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

Guidance for industry on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

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June 18, 2024 at 06:13PM What happens after a Patient Listening Session?

Learn about what happens after a Patient Listening Session occurs and check out summaries from previous sessions on our website.

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June 18, 2024 at 05:28PM Blood Products Advisory Committee May 9, 2024 Meeting Announcement - 05/09/2024

This is the main page for the Blood Products Advisory Committee May 9, 2024 Meeting Announcement and meeting materials.

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June 18, 2024 at 04:45PM 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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June 18, 2024 at 03:20PM Neobiosis, LLC - 662985 - 06/05/2024

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

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June 17, 2024 at 06:00PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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June 14, 2024 at 10:01PM Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies.

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Cucumber Recall Update As FDA Sets Highest Risk Level - Newsweek

1. Cucumber Recall Update As FDA Sets Highest Risk Level  Newsweek
2. FDA cucumber recall: Salmonella cases rise among those who ate them  USA TODAY
3. Publisher's Platform: Fresh Start Produce – I would not claim that your cucumbers are not the cause of the Salmonella outbreak  Food Safety News
4. Salmonella outbreak from recalled cucumbers impacts Delaware, What you should know  The News Journal
5. Florida cucumbers recalled for salmonella might not be outbreak source  Daytona Beach News-Journal

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Cucumber Recall Update As FDA Sets Highest Risk Level - Newsweek

1. Cucumber Recall Update As FDA Sets Highest Risk Level  Newsweek
2. FDA cucumber recall: Salmonella cases rise among those who ate them  USA TODAY
3. Cucumber Recall Update as FDA Reveals Hospitalizations, Map  Newsweek
4. Publisher's Platform: Fresh Start Produce – I would not claim that your cucumbers are not the cause of the Salmonella outbreak  Food Safety News
5. Florida cucumbers recalled for salmonella might not be outbreak source  Daytona Beach News-Journal

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June 14, 2024 at 08:52PM 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

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June 14, 2024 at 03:12AM 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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June 14, 2024 at 01:32AM 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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June 13, 2024 at 10:03PM Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024.



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June 13, 2024 at 03:57PM Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires

Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires, CBER, biologics, guidance, industry, blood, donor, questionnaire

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June 13, 2024 at 03:38PM FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information

Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information, CBER, Biologics

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June 11, 2024 at 09:21PM 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 12, 2024 at 03:13PM VAXCHORA

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.

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June 11, 2024 at 09:35PM FDA Roundup: June 11, 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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June 11, 2024 at 07:13PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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June 10, 2024 at 03:36PM BIMO/Team Biologics/Internet Surveillance/Other

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

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June 07, 2024 at 09:44PM FDA Roundup: June 7, 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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June 07, 2024 at 07:37PM 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 07, 2024 at 03:20PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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June 06, 2024 at 03:10PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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Cucumbers linked to salmonella outbreak that has spread to 25 states - CBS News

1. Cucumbers linked to salmonella outbreak that has spread to 25 states  CBS News
2. Salmonella Outbreak Linked to Cucumbers  CDC
3. Cucumbers shipped to 14 states recalled over Salmonella concerns  NBC News
4. Outbreak Investigation of Salmonella: Cucumbers (June 2024)  FDA.gov
5. More than 160 sickened in salmonella outbreak potentially linked to recalled cucumbers  CNN

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Cucumbers linked to salmonella outbreak that has spread to 25 states - CBS News

1. Cucumbers linked to salmonella outbreak that has spread to 25 states  CBS News
2. Salmonella Outbreak Linked to Cucumbers  CDC
3. Cucumbers shipped to 14 states recalled over Salmonella concerns  NBC News
4. Outbreak Investigation of Salmonella: Cucumbers (June 2024)  FDA.gov
5. Two dozen sickened across NY, NJ and CT due to salmonella outbreak from cucumbers: CDC  NBC New York

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Cucumber recall: FDA investigating cucumbers in nationwide Salmonella outbreak that's sent 54 to the hospital - NBC News

1. Cucumber recall: FDA investigating cucumbers in nationwide Salmonella outbreak that's sent 54 to the hospital  NBC News
2. Cucumbers shipped to 14 states recalled over Salmonella concerns  NBC News
3. Salmonella Outbreak Linked to Cucumbers  CDC
4. Cucumbers Recalled Over Possible Salmonella Contamination  Health.com
5. 162 sickened in Salmonella outbreak linked to cucumbers: CDC  The Hill

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June 05, 2024 at 04:45PM 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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June 05, 2024 at 04:40PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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June 05, 2024 at 02:30PM Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions

This is the Draft Guidance for Industry Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions

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June 04, 2024 at 08:28PM FDA Roundup: June 4, 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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June 04, 2024 at 03:01PM Processes and Practices Applicable to Bioresearch Monitoring Inspections

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry

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Cucumber recall in 14 states, including Ohio - WJW FOX 8 News Cleveland

1. Cucumber recall in 14 states, including Ohio  WJW FOX 8 News Cleveland
2. Recalled cucumbers may be source of ongoing Salmonella outbreak  Food Safety News
3. Cucumber recall 2024: Salmonella fears, stores in list of 14 states  Fast Company
4. Have the CDC and FDA found cucumbers to be the source of the Salmonella Africana Outbreak?  Marler Blog
5. Cucumbers recalled in 14 states due to potential salmonella contamination  KOMO News

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Cucumbers recalled across 14 states over potential Salmonella contamination - Daily Mail

1. Cucumbers recalled across 14 states over potential Salmonella contamination  Daily Mail
2. Recalled cucumbers may be source of ongoing Salmonella outbreak  Food Safety News
3. Cucumber Recall in 14 States As Warning Issued to Customers  Newsweek
4. Have the CDC and FDA found cucumbers to be the source of the Salmonella Africana Outbreak?  Marler Blog
5. Cucumbers recalled in 14 states over Salmonella concerns  USA TODAY

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Cucumbers recalled in 14 states over Salmonella concerns - USA TODAY

1. Cucumbers recalled in 14 states over Salmonella concerns  USA TODAY
2. Recalled cucumbers may be source of ongoing Salmonella outbreak  Food Safety News
3. Cucumber Recall in 14 States As Warning Issued to Customers  Newsweek
4. Recall alert: Fresh Start recalls cucumbers over possible salmonella link  WHIO
5. Past Salmonella Outbreaks tied to Cucumbers  Food Poison Journal

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Cucumber Recall in 14 States As Warning Issued to Customers - Newsweek

1. Cucumber Recall in 14 States As Warning Issued to Customers  Newsweek
2. Recalled cucumbers may be source of ongoing Salmonella outbreak  Food Safety News
3. Recall alert: Fresh Start recalls cucumbers over possible salmonella link  WHIO
4. Cucumbers recalled in 14 states over Salmonella concerns  USA TODAY
5. Past Salmonella Outbreaks tied to Cucumbers  Food Poison Journal

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