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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 […]
August 4, 2020

New Life International – 609499 – 07/21/2020

Delivery Method: Via Overnight Delivery Product: Animal & VeterinaryDrugs Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: July 21, 2020 RE: Unapproved Chloroquine […]
August 4, 2020

Fishman Chemical of North Carolina, LLC – 609362 – 07/21/2020

Delivery Method: Via Overnight Delivery Product: Animal & VeterinaryDrugs Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: July 21, 2020 RE: Unapproved New […]
August 4, 2020

Draft: Safe Disposal of Medicines

Medicines play an important role in treating certain conditions and diseases, but they must be taken with care. Unused portions of these medicines must be disposed […]
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