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December 8, 2020

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry

Submit Comments by 02/08/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
December 8, 2020

Paradigm RE LLC – 612014 – 12/07/2020

Product: Drugs Date:               December 7, 2020 RE:      Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United […]
December 8, 2020

Valentus, Inc. – 609611 – 11/30/2020

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Dave Jordan Recipient Title Owner Valentus, Inc. 3900 W. 53rd StreetSioux Falls, SD 57106-4220United States […]
December 8, 2020

Natures Boost LLC – 609846 – 11/20/2020

Delivery Method: Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Nathan Howerton and Tanner Vaughn Recipient Title Member(s) Natures Boost LLC 9805 Northeast 116th Street, […]
December 8, 2020

Corporativo Bureli S.A. de C.V. – 610304 – 12/01/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jorge Bermudez Cardona Recipient Title CEO Corporativo Bureli S.A. de C.V. Lazaro Cardenas No. 10 San […]
December 8, 2020

Mushroom Revival, Inc. – 610361 – 12/01/2020

Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Mr. Alexander Warner Dorr Recipient Title Manager Mushroom Revival, Inc. 54 West StreetEasthampton, MA 01027United States […]
December 7, 2020

Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine – 12/04/2020

Thank you for being here today for this important conversation, and to be sharing the computer screen with our colleagues under the HHS umbrella, all of […]
December 7, 2020

Remarks by Dr. Hahn to the FDA-CMS Summit – 12/07/2020

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration [embedded content] I’m delighted to be with you […]
December 7, 2020

Drug Trials Snapshots: IMCIVREE

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
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