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September 15, 2020

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment – 10/15/2020 – 10/16/2020

On This Page Date: October 15 – 16, 2020 Day1: Thu, Oct 15 8:00 AM – 10:30 AM ET Day2: Fri, Oct 16 8:00 AM – […]
September 15, 2020

La Vita Compounding Pharmacy, LLC – 575286 – 02/28/2019

WARNING LETTER   VIA SIGNATURE CONFIRMED DELIVERY   February 28, 2019   Christine Givant Pharmacist-In-Charge La Vita Compounding Pharmacy, LLC 3978 Sorrento Valley Boulevard, Suite 300 […]
September 15, 2020

Sprout Pharmaceuticals, Inc – 610569 – 08/31/2020

Product: Drugs Recipient: Recipient Name Cindy Eckert Recipient Title Chief Executive Officer Sprout Pharmaceuticals, Inc 4350 Lassiter at North Hills Avenue, #260Raleigh, NC 27609United States Issuing […]
September 15, 2020

Mayon’s Pharmaceuticals Pvt Ltd – 607388 – 09/04/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Yusuf MH Chimthanawala Recipient Title Chief Executive Officer Mayon’s Pharmaceuticals Pvt Ltd 576 Quaemi Bagh, Near […]
September 15, 2020

Kalchem International, Inc. – 607098 – 08/27/2020

Delivery Method: VIA Electronic Mail Reference #: 1000149906 Product: Drugs Recipient: Recipient Name Kalyn R. Tabor Recipient Title President Kalchem International, Inc. 224 S. Main St.Suite […]
September 15, 2020

Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

Submit Comments by 11/16/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
September 15, 2020

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry

Docket Number: FDA-2019-D-0177 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
September 14, 2020

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Docket Number: FDA-2020-D-1824 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays a critical role in […]
September 14, 2020

Centurion Labs Issues Voluntary Nationwide Recall of Ninjacof (Lot # 200N1601) and Ninjacof A (Lot# 201NA1601) Products Due to Potential Burkholderia Cepacia Contamination

Summary Company Announcement Date: August 22, 2017 FDA Publish Date: February 06, 2018 Product Type: DrugsFood & Beverages Generic Drugs Reason for Announcement: Recall Reason Description […]
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