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May 30, 2023

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 […]
May 30, 2023

FDA Roundup: May 30, 2023

For Immediate Release: May 30, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, […]
May 30, 2023

Drug Trials Snapshot: NEXVIAZYME

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
May 30, 2023

[email protected] Data Files

Below you will find a compressed data file of the [email protected] database. It does not include the scripts (programming) we use to produce the online version […]
May 26, 2023

FDA Roundup: May 26, 2023

For Immediate Release: May 26, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]
May 26, 2023

FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions.

[Posted 05/26/2023]  AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics   ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information […]
May 26, 2023

Abbreviated New Drug Application (ANDA)

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, […]
May 26, 2023

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products

Submit Comments by 08/24/2023 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 […]
May 26, 2023

FDA updates on hand sanitizers consumers should not use

Yiwu Mango Cosmetics, Ltd.(China) Instant Hand Sanitizer (Alcohol 75%) 76824-001-0176824-001-0276824-001-0376824-001-0476824-001-0576824-001-0676824-001-0776824-001-0876824-001-0976824-001-1076824-001-1176824-001-1276824-001-13 Yiwu Mango Cosmetics, Ltd.(China) Product manufactured at a facility that did not respond to multiple FDA […]
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