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May 26, 2021

Drug Interactions & Labeling

March 2021 Update: The FDA announces new regulatory guidance on assessing pH-dependent drug interactions Preventing and Mitigating Drug Interactions Overview Patients frequently use more than one […]
May 26, 2021

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

[Posted 05/26/2021]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis […]
May 26, 2021

Drug Development and Drug Interactions: Advisory Committee Meetings

2013 2012  no ACPS-CP meeting 2011 2010 2009  no ACPS-CP meeting 2008 2007  no ACPS-CP meeting 2006 2005 Evidence and Process for Translation of Pharmacogenetic Information […]
May 26, 2021

Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis

FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with use of Ocaliva reported in the FDA Adverse Event […]
May 26, 2021

Complex Innovative Trial Design Pilot Meeting Program

On this page As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program […]
May 26, 2021

LeRoche Benicoeur dba ConceiveEasy – 613647 – 05/20/2021

Product: Drugs Recipient: Recipient Name Mary Whittaker LeRoche Benicoeur dba ConceiveEasy 1130 Fremont Blvd #301Seaside, CA 93955United States Issuing Office: United States WARNING LETTER May 20, […]
May 26, 2021

Remarks by Dr. Woodcock to the FDA Science Forum and introduction of Dr. Fauci – 05/26/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration Thank you, Denise [RADM Hinton], for that introduction and for […]
May 26, 2021

Medically Minded Hand Sanitizer– Nationwide Recall Expansion Due to The Presence of Undeclared Methanol

Summary Company Announcement Date: May 20, 2021 FDA Publish Date: May 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company […]
May 25, 2021

Complex Innovative Trial Design Pilot Meeting Program Frequently Asked Questions

Response: Officially launched with the publication of a Federal Register Notice in August 2018, the CID Pilot Meeting Program is a U.S. Food and Drug Administration […]
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