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June 9, 2021

Oncology (Cancer) / Hematologic Malignancies Approval Notifications

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for […]
June 9, 2021

Core Patient-Reported Outcomes in Cancer Clinical Trials

Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to […]
June 8, 2021

Electronic Registration and Listing Compliance Program

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, […]
June 8, 2021

Coronavirus (COVID-19) Update: June 8, 2021

For Immediate Release: June 08, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 8, 2021

S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals

Docket Number: FDA-1996-D-0010 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The objectives of carcinogenicity studies are to identify a tumorigenic potential in […]
June 8, 2021

Drug Development and Drug Interactions | Possible Models for Decision-Making

Drug Development and Drug Interactions: Possible Models for Decision-Making Possible Model for Decision Making: Metabolism-Based Drug-Drug Interaction Studies (Figures 1-4). Possible Model for Decision Making: Transporter-Based […]
June 8, 2021

Executive Order 14017 on America’s Supply Chains

Image Introduction Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United […]
June 8, 2021

DMM Vission, S.A. de C.V. – 609797 – 06/03/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ma. de la Luz Escorza Recipient Title CEO DMM Vission, S.A. de C.V. Calle Lago Guija 234Col. […]
June 8, 2021

PurePurge Inc. – 613194 – 06/02/2021

Product: Drugs Recipient: Recipient Name Gordon Wood Recipient Title Chief Executive Officer PurePurge Inc. 2630 Homestead PlaceRancho Dominguez, CA 90220United States Issuing Office: Center for Drug […]
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