fbpx
November 24, 2020

Public Meeting on Patient-Focused Drug Development for Vitiligo – 03/08/2021 – 03/08/2021

On This Page Date: March 8, 2021 Time: 10:00 AM – 2:30 PM ET On March 8, 2021, FDA is hosting a virtual public meeting on […]
November 24, 2020

Harmonic Nature S. de R.L. MI. – 609367 – 11/16/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Miguel Martinez Recipient Title Owner Harmonic Nature S. de R.L. MI. Lacandon 20567150 Guadalupe, N.L.Mexico Issuing […]
November 24, 2020

Liq-E S.A. De C.V. – 609128 – 11/19/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Jose Luis Rodriguez Recipient Title General Director Liq-E S.A. De C.V. Calle Puerto Tampico No. 345Col. La […]
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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0