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September 23, 2020

FDA requires Boxed Warning updated to improve safe use of benzodiazepine drug class

We reviewed postmarketing databases and the published literature on the use of benzodiazepines and associated abuse, misuse, addiction, and physical dependence. In 2019, an estimated 92 […]
September 23, 2020

Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act

About OTC Monograph Reform On Friday, March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts […]
September 23, 2020

It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments

Image By: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner When a patient is in need of an important medicine, paperwork and forms are the last thing […]
September 22, 2020

Guidances (Drugs)

About FDA Guidances Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any […]
September 22, 2020

Information by Drug Class

The following pages contain safety, regulatory and availability information. For information on specific drugs, please see the Index to Drug-Specific Information. Resources For You Content current […]
September 22, 2020

HNC Products Inc. – 607359 – 09/10/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Dr. Vishnu Potini Recipient Title President HNC Products Inc. 1619 Commerce ParkwayBloomington, IL 61704United States Issuing […]
September 22, 2020

Coupler Enterprises – 607662 – 09/15/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Wayne Shafer Recipient Title Owner Coupler Enterprises 125 Titus Ave, Suite 200Warrington, PA 18976-2424United States [email protected] […]
September 22, 2020

Integrated Health Concepts Inc. dba Conversio Health – 610546 – 09/10/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Taylor Cline Recipient Title CEO Integrated Health Concepts Inc. dba Conversio Health 720 Aerovista Place, Suite DSan […]
September 22, 2020

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy – 610384 – 09/08/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Dawn Hoang, R.Ph. Recipient Title Owner First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 6828 […]
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