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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 […]
July 6, 2021

FDA’s Budget: Data Modernization and Enhanced Technologies

Image By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs The U.S. Food and Drug Administration’s mission to protect and promote the public health impacts […]
July 2, 2021

Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products

Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983. It became widely used over the ensuing decades as a prescription and over-the-counter […]
July 1, 2021

Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink Containers

Summary Company Announcement Date: July 01, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaged in bottles that […]
July 1, 2021

Public Notification: Genesis Ultra Slim Gold contains hidden drug ingredients

[7-1-2021] The Food and Drug Administration is advising consumers not to purchase or use Genesis Ultra Slim Gold, a product promoted and sold for weight loss […]
July 1, 2021

Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter

Summary Company Announcement Date: June 30, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter […]
July 1, 2021

Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications

Docket Number: FDA-2020-D-2323 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations for clinical trials designed to assess the adhesion […]
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