July 30, 2024 at 09:36PM FDA Roundup: July 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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July 30, 2024 at 06:01PM 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, and pregnant individuals at 32 through 36 weeks gestational age.


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Monday, July 29, 2024

July 29, 2024 at 08:27PM Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

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July 26, 2024 at 03:52PM Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use

This is the Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use.

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July 26, 2024 at 03:48PM FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products

This is the FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products

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Thursday, July 25, 2024

July 25, 2024 at 05:14PM 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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Wednesday, July 24, 2024

July 24, 2024 at 03:46PM Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

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Tuesday, July 23, 2024

July 23, 2024 at 09:38PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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July 23, 2024 at 05:06PM 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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July 21, 2024 at 04:55PM Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry

This is the Guidance for Industry, Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma

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Thursday, July 18, 2024

July 18, 2024 at 03:00PM Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Lyme disease is on the rise. How can you prevent it? What are the symptoms, and what should you do if you think you or your pet have it?

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Wednesday, July 17, 2024

July 17, 2024 at 02:21PM Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

This is the guidance Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

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Tuesday, July 16, 2024

July 16, 2024 at 10:24PM 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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July 16, 2024 at 03:20PM Massachusetts Institute of Technology MIT - 663218 - 06/21/2024

Bioresearch Monitoring Program/IRB

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July 16, 2024 at 02:44PM Application User Fees for Combination Products

Revised final guidance on PDUFA and MDUFA application user fees for combination products. For combination products with a single or separate application(s), it explains how FDA applies user fees.

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July 16, 2024 at 02:28PM Emergency Dispensing Orders and Emergency Use Instructions (EUI)

The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

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Monday, July 15, 2024

July 15, 2024 at 03:57PM Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, CBER, Biologics

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Thursday, July 11, 2024

July 12, 2024 at 12:40AM 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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July 11, 2024 at 04:00PM Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases - 09/20/2024

FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

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Tuesday, July 9, 2024

July 10, 2024 at 12:13AM 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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July 09, 2024 at 03:32PM Charter of the Vaccines and Related Biological Products Advisory Committee

This is the Charter of the Vaccines and Related Biological Products Advisory Committee.

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July 09, 2024 at 03:20PM New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank - 681776 - 06/20/2024

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

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Monday, July 8, 2024

July 08, 2024 at 08:25PM Consumer Updates

Science-based health and safety information you can trust.

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July 08, 2024 at 04:58PM 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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Wednesday, July 3, 2024

July 04, 2024 at 12:12AM Executive Order 14017 on America’s Supply Chains

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

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Tuesday, July 2, 2024

July 01, 2024 at 09:17PM 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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July 02, 2024 at 05:26PM FDA Voices

Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco.

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