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November 24, 2020

Aurolife Pharma, LLC – 607087 – 10/16/2020

Delivery Method: Certified Mail Product: Drugs Recipient: Recipient Name Mr. Madan Mohan Reddy Recipient Title Director of Operations Aurolife Pharma, LLC Plot No. 11, Survey No. […]
November 24, 2020

Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff

Docket Number: FDA-2010-D-0529 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Section 3011 of the 21st Century […]
November 24, 2020

OPDP eCTD

On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human […]
November 23, 2020

FDA Approves First Drug to Treat Rare Metabolic Disorder

For Immediate Release: November 23, 2020 Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), […]
November 23, 2020

Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

Summary Company Announcement Date: November 22, 2020 FDA Publish Date: November 23, 2020 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Unapproved new drug […]
November 23, 2020

Why the United States-Mexico-Canada Agreement is Important to FDA

Image By: Anne Kirchner, J.D., and Joseph Rieras, J.D., Senior Advisors in FDA’s Office of Trade, Mutual Recognition, and International Arrangements FDA was an important member […]
November 23, 2020

CDER Compliance Conference – 01/14/2021 – 01/14/2021

On This Page Date: January 14, 2021 Time: 8:30 AM – 4:30 PM ET This conference is FREE. In SBIA’s first conference dedicated to compliance, participants […]
November 22, 2020

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

For Immediate Release: November 21, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered […]
November 20, 2020

FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

For Immediate Release: November 20, 2020 Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford […]
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