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August 5, 2020

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical conformance guide, when finalized, will represent the current thinking of the Food and […]
August 5, 2020

Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway

On December 13, 2016, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) was added to the Federal Food, Drug, and Cosmetic (FD&C) Act […]
August 5, 2020

Roque Plast S.A. de C.V. Issues Voluntary Nationwide Recall of Command Brands Gel AntiBac Instant Hand Sanitizer Lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 Due to Potential Presence of Methanol (Wood Alcohol)

Summary Company Announcement Date: August 04, 2020 FDA Publish Date: August 04, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Methanol Contamination Company Name: […]
August 4, 2020

FDA Study Data Technical Conformance Guide – 11/27/2018 – 11/27/2018

On This Page Date: November 27, 2018 Time: 1:30 PM – 2:30 PM ET Organized By: [embedded content] Tuesday, November 27, 20181:30pm – 2:30pm (Eastern)  The […]
August 4, 2020

Inactive Ingredients Database Download

The Inactive Ingredients files are supplied as comma delimited text and Excel files. The size of each unzipped file is less than 2 MB. We update […]
August 4, 2020

Biosimilar User Fee Amendments

What are the BPD Fees?BPD fees are assessed for products in FDA’s BPD program. BPD fees include the initial BPD fee, the annual BPD fee, and […]
August 4, 2020

MMSTabs.com – 609461 – 08/03/2020

Product: Drugs Date:   August 3, 2020 RE:       Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)   This is to advise you that the […]
August 4, 2020

Information for Health Care Facilities and Providers on “in-use time” | COVID-19

Information for Health Care Facilities and Providers on “in-use time”  FDA is aware that some health care facilities and providers are facing challenges in maintaining adequate […]
August 4, 2020

ACRX Specialty Pharmacy Inc. – 609518 – 07/24/2020

Delivery Method: VIA SIGNATURE CONFIRMED DELIVE Product: Drugs Recipient: Recipient Name Eghomware J. Igbinovia Recipient Title Owner and Pharmacist-In-Charge ACRX Specialty Pharmacy Inc. 3200 Soaring Gulls […]
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