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November 25, 2022

Guidance Webinar Series

FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders. The first-in-a-series of Guidance Webinars […]
November 23, 2022

Charging for Investigational Drugs Under an IND – Questions and Answers

Docket Number: FDA-2013-D-0447 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides information for industry, […]
November 22, 2022

Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

[Posted 11/22/2022]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced […]
November 22, 2022

Drug Trial Snapshot: EVKEEZA

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
November 22, 2022

Rosebud’s Ranch and Garden, LLC – 628567 – 10/18/2022

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Amber R. Stephenson Recipient Title Owner Rosebud’s Ranch and Garden, LLC 122 W High […]
November 22, 2022

The Truth Company, LLC – 611501 – 11/14/2022

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Nathaneal Mohr Recipient Title CEO The Truth Company, LLC 6325 Spine RdBoulder, CO 80301United States […]
November 22, 2022

goodimmuno.com – 642697 – 11/14/2022

Product: Drugs Recipient: goodimmuno.com United States Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: Notice of Unlawful Sale of Unapproved and […]
November 22, 2022

yourtramadol.com – 639959 – 11/14/2022

Product: Drugs Recipient: yourtramadol.com United States Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: Notice of Unlawful Sale of Unapproved and […]
November 21, 2022

Public Notification: JACK’D Sexual Enhancement Capsules contain hidden drug ingredient

[11-21-2022] The Food and Drug Administration is advising consumers not to purchase or use, JACK’D Sexual Enhancement Capsules, a product promoted and sold for sexual enhancement […]
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