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July 14, 2020

An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, Patrizia Cavazzoni, M.D., Acting Director, Center for Drug Evaluation and Research, and Peter Marks, M.D., […]
July 14, 2020

Netcos Co., Ltd. – 565521 – 10/29/2018

WARNING LETTER     VIA UNITED PARCEL SERVICE                                                          SIGNATURE REQUIRED October 29, 2018              WL # 1326 Bae Tae-Jong Netcos Co. Ltd. 3/F Seocho-dong 23- 12 […]
July 14, 2020

Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19

FDA’s Role in Reviewing Research Proposals for Patient Safety FDA has a critical role in ensuring the safety of patients in clinical trials studying drugs or […]
July 14, 2020

Kegan Wellness – 608737 – 07/13/2020

Product: Drugs Recipient: Kegan Wellness 602, Aarohi Verve, Besides One World West BuildingAmbli Bopal Cross Road, Sardar Patel Ring RoadAhmedabad 380058GujaratIndia [email protected] Date:               July 13, 2020 […]
July 14, 2020

Health Beauty Love – 608979 – 07/10/2020

Delivery Method: [email protected] Product: Drugs Date:                July 10, 2020 RE:                   Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to […]
July 13, 2020

Controle su asma: conozca los detonantes y sus opciones de tratamiento

Image English El asma es una enfermedad pulmonar crónica que hace que las vías respiratorias se inflamen y estrechen. Los síntomas de un episodio o ataque […]
July 13, 2020

Manage Your Asthma: Know Your Triggers and Treatment Options

Image Español Asthma is a chronic lung disease that causes the airways to become inflamed and narrow. Symptoms of an asthma attack can include coughing, wheezing […]
July 13, 2020

4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)

BLUMENAdvancedInstant HandSanitizerClear 60599-015-00 33.8 fl oz / 1L 814266023747 2213, 2219, 2220, 2221, 2223, 2225, 2252, 2255,2226, 2227, 2254, 2467,2244, 2247, 2229, 2845,2847, 2212, 2217, 2222,2250, […]
July 13, 2020

Resources for Biomarker Requestors

How to engage with the Biomarker Qualification Program (BQP) If you have pre-submission or general inquiry questions or you want to make a meeting request, please […]
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