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September 8, 2020

Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations – 06/30/2020

Keynote Address ShaAvhrée Buckman-GarnerDirectorOffice of Translational Sciences (OTS) Bioanalytical Method Validation: History, Process, and Regulatory Perspectives Patrick FaustinoLab ChiefDivision of Product Quality Research (DPQR)Office of Testing […]
September 8, 2020

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer 

On September 8, 2020, the Food and Drug Administration alerted health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of […]
September 8, 2020

FDA approves pralsetinib for lung cancer with RET gene fusions

On September 4, 2020, the Food and Drug Administration granted accelerated approval to pralsetinib (GAVRETOTM, Blueprint Medicines Corporation) for adult patients with metastatic RET fusion-positive non-small […]
September 8, 2020

Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations – 09/16/2020 – 09/16/2020

On This Page Date: September 16, 2020 Time: 12:00 AM – 12:00 AM ET Slides ABOUT This webinar encourages the use of Drug Master Files (DMFs) […]
September 8, 2020

FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

[9/08/2020] FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients […]
September 8, 2020

Renewal Supplements LLC – 608749 – 08/25/2020

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Mr. Vincent Manzo Renewal Supplements LLC 135 Weston Road, Suite 138Weston, FL 33326United States […]
September 8, 2020

PT. MegaSurya Mas – 604366 – 08/24/2020

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Alok Kumar Jain Recipient Title President Director PT. MegaSurya Mas J1 Tambak Sawah 32SidoarjoJawa Timur […]
September 8, 2020

Savvy Holistic Health dba Holistic Healthy Pet – 610273 – 08/25/2020

Delivery Method: Via Overnight Delivery Product: Animal & VeterinaryDrugs Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: August 25, 2020 CC: [email protected] RE: […]
September 8, 2020

Calvin Scott & Company, Inc. – 606987 – 08/25/2020

Delivery Method: VIA SIGNATURE CONFIRMED DELIVE Product: Drugs Recipient: Recipient Name Mr. Jan-Erik Palm Recipient Title President Calvin Scott & Company, Inc. 1104 W Bay AveNewport […]
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