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July 9, 2021

Public Notification: Cholestene contains hidden drug ingredient

[7-9-2021] The Food and Drug Administration is advising consumers not to purchase or use Cholestene, a product promoted and sold for cholesterol management on various websites […]
July 8, 2021

Halodine, LLC – 611150 – 07/07/2021

Product: Drugs Recipient: Recipient Name Jesse Pelletier, MD Recipient Title President Halodine, LLC 111 NE 1st St, Suite 806Miami, FL 33132-2506United States [email protected] Issuing Office: Center […]
July 8, 2021

Clinical Data Summary Pilot Program

The Center for Drug Evaluation and Research (CDER) is committed to improving efficiency and transparency in the drug approval process. Consistent with this goal, in 2018 CDER launched […]
July 7, 2021

Drug Development Tool Qualification Process: Transparency Provisions

Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal […]
July 7, 2021

Stason Pharmaceuticals, Inc. – 604889 – 06/24/2021

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Harry T. Fan Recipient Title Chief Executive Officer Stason Pharmaceuticals, Inc. 11 MorganIrvine, CA 92618United […]
July 6, 2021

Spectrum Laboratory Products, Inc. – 573311 – 06/24/2021

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Russell Kneipp Recipient Title Chief Operating Officer Spectrum Laboratory Products, Inc. 14422 S. San Pedro […]
July 6, 2021

Spectrum Laboratory Products – 573311 – 06/04/2019

Delivery Method: VIA SIGNATURE CONFIRMED DELIVE Product: Drugs Recipient: Recipient Name Mr. Randy Burg Recipient Title President/CEO Spectrum Laboratory Products 14422 S. San Pedro StreetGardena, CA […]
July 6, 2021

Results RNA, LLC – 578997 – 06/24/2021

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name David Larson Recipient Title CEO and President Results RNA, LLC 1272 S. 1380 WOrem, UT […]
July 6, 2021

Results RNA, LLC – 578997 – 07/29/2019

Delivery Method: VIA SIGNATURE CONFIRMED DELIVE Product: Drugs Recipient: Recipient Name Mr. David L. Larson Recipient Title CEO and President Results RNA, LLC 1272 S 1380 […]
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