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February 23, 2021

CooperSurgical, Inc. – 613339 – 02/12/2021

Product: Drugs Recipient: Recipient Name Holly Sheffield Recipient Title President CooperSurgical, Inc. 75 Corporate DriveTrumbull, CT 06611United States Issuing Office: The Office of Prescription Drug Promotion […]
February 22, 2021

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung […]
February 22, 2021

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

For Immediate Release: February 22, 2021 Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, […]
February 22, 2021

Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA plays a critical role in protecting the United States from threats […]
February 19, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Sucesos adversos graves resultantes de ingestión accidental por niños de colirios (gotas para los ojos) y aerosoles nasales de venta libre

Anuncio de seguridadInformación adicional para consumidores y padres de familia/cuidadoresInformación adicional para profesionales de la saludResumen de datosLista de productosReferencias Anuncio de seguridad El 25 de […]
February 19, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Severas reacciones cutáneas después de tratamiento combinado con los medicamentos Incivek (telaprevir), peginterferón alfa y ribavirina para la hepatitis C

Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos Anuncio de seguridad El 19 de diciembre del 2012, La Administración de […]
February 19, 2021

The 15th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2021 – 04/14/2021 – 04/16/2021

On This Page Date: April 14 – 16, 2021 Time: 10:00 AM – 3:45 PM ET Location: Virtual Event Co-Sponsor: Drug Information Association (DIA) https://www.diaglobal.org/en/conference-listing/meetings/2021/04/biostatistics-industry-and-regulator-forum Background: […]
February 19, 2021

Native Remedies dba Silver Star Brands – 612268 – 02/18/2021

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Bruce Valk Native Remedies dba Silver Star Brands 250 City CenterOshkosh, WI 54906United States […]
February 19, 2021

FDC Nutrition Inc. – 612264 – 02/18/2021

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Quanzheng Sui Recipient Title CEO FDC Nutrition Inc. 2313 East Philadelphia Street Ste LOntario, […]
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