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May 26, 2020

FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

For Immediate Release: May 26, 2020 The U.S. Food and Drug Administration today granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by […]
May 26, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

For Immediate Release: May 26, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 26, 2020

Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations for industry and review staff […]
May 26, 2020

Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides guidance for industry on changes to the policies and procedures being used […]
May 26, 2020

Regulatory Policy Information | Sunscreen Innovation Act

Federal Register (FR) notice FR Notice of Availability of Proposed Orders for six sunscreen ingredients that were previously issued feedback letters  1/10/2015 1/7/2015 Sunscreen Feedback Letters; […]
May 26, 2020

2018-NCTR Research Highlights

  ARCHIVE TOPICS  October-December 2018 Microbiome Research at NCTR — Tobacco, Arsenic, and more… NCTR Represented at the Health and Environmental Sciences Institute’s (HESI) “The Gut Microbiome […]
May 26, 2020

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy – 598303 – 01/13/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Roy C. Anderson, RPh Recipient Title Owner and CEO Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy […]
May 26, 2020

Altaire Pharmaceuticals, Inc. – 586153 – 03/12/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Assad S. Sawaya Recipient Title President & CEO Altaire Pharmaceuticals, Inc. P.O. Box 849311 W LnAquebogue, […]
May 26, 2020

Humaworm – 593083 – 04/20/2020

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Reba G. Bailey Recipient Title Owner Humaworm 609 Lexington StreetP. O. Box 190Carrollton, MS […]
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