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November 24, 2020

Public Notification: Magnum XXL 50K contains hidden drug ingredient

[11-24-2020] The Food and Drug Administration is advising consumers not to purchase or use Magnum XXL 50K, a product promoted for sexual enhancement. This product was […]
November 24, 2020

Drug Safety Oversight Board

The DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the CDER Center Director on the handling and communicating […]
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), […]
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