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Archive for November, 2022

FDA Approves First Gene Therapy to Treat Adults with Hemophilia B

November 22, 2022

FDA Approves First Gene Therapy to Treat Adults with Hemophilia B

Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B…

FDA Approves First Gene Therapy to Treat Adults with Hemophilia B FDA
FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

November 17, 2022

FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or…

FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease FDA
FDA Spurs Innovation for Human Food from Animal Cell Culture Technology

November 16, 2022

FDA Spurs Innovation for Human Food from Animal Cell Culture Technology

The world is experiencing a food revolution and the U.S. Food and Drug Administration is committed to supporting innovation in the food supply. As an…

FDA Spurs Innovation for Human Food from Animal Cell Culture Technology FDA
FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters

November 16, 2022

FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters

Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product…

FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters FDA
FDA Mengalami Kemajuan di Era Baru Keamanan Pangan yang Lebih Cerdas, Memfinalisasi Aturan Dasar untuk Meningkatkan Keterlacakan Makanan Terkontaminasi

November 15, 2022

FDA Mengalami Kemajuan di Era Baru Keamanan Pangan yang Lebih Cerdas, Memfinalisasi Aturan Dasar untuk Meningkatkan Keterlacakan Makanan Terkontaminasi

Hari ini, Badan Pengawas Obat dan Makanan AS mengumumkan kemajuan yang belum pernah terjadi sebelumnya dalam pencegahan penyakit yang ditularkan melalui makanan melalui finalisasi aturan…

FDA Mengalami Kemajuan di Era Baru Keamanan Pangan yang Lebih Cerdas, Memfinalisasi Aturan Dasar untuk Meningkatkan Keterlacakan Makanan Terkontaminasi FDA
FDA Roundup: November 15, 2022

November 15, 2022

FDA Roundup: November 15, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA issued an Emergency Use…

FDA Roundup: November 15, 2022 FDA
FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods

November 15, 2022

FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods

Today, the U.S. Food and Drug Administration announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace…

FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods FDA
FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs

November 15, 2022

FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs

Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of…

FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs FDA
FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

November 15, 2022

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

  Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products  Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and…

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use FDA
Study Subject Site Transfers Example

November 13, 2022

Study Subject Site Transfers Example

This article provides a good example for documenting study subject site transfers, using existing SDTMIG domains and minimal supplemental qualifiers. Originally modeled for COVID studies,…

Study Subject Site Transfers Example CDISC

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