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March 15, 2021

Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021 – 05/18/2021 – 05/19/2021

On This Page Date: May 18 – 19, 2021 Time: 1:00 PM – 1:00 PM ET Times: May 18: 1 – 4pm | May 19: 10am […]
March 15, 2021

Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs […]
March 15, 2021

Office of New Drugs (OND) | Annual Reports

2020 marked the first year the Office of New Drugs (OND) developed an Annual Report. This report offers readers insight into OND’s priorities through a message […]
March 15, 2021

Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials – 613639 – 03/12/2021

Product: Drugs Date:               March 12, 2021 RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that […]
March 12, 2021

April 27-29, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 04/27/2021 – 04/29/2021

On This Page Date: April 27 – 29, 2021 Time: 1:00 PM – 5:30 PM ET Center Date Time Location CDER April 27, 2021 April 28, 2021April […]
March 12, 2021

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

Summary Company Announcement Date: March 11, 2021 FDA Publish Date: March 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance […]
March 11, 2021

Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference – 03/11/2021

Speech by Denise Hinton Leadership Role (Remarks as prepared for delivery) I’m delighted to be with you for this important meeting. Your agenda encompasses many of […]
March 11, 2021

Metuchen Pharmaceuticals, LLC – 590713 – 09/18/2020

Reference #: NDA 202276 Product: Drugs Recipient: Recipient Name Fady Boctor Metuchen Pharmaceuticals, LLC 200 US Hwy 9 Suite 500Manalapan, NJ 07726United States Issuing Office: Office […]
March 11, 2021

The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels

The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels to include dosing in patients with creatinine clearance between 30 and […]
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