The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...

Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

The Senate Committee on Health, Labor and Pensions voted Thursday to approve Marty Makary as commissioner of the Food and Drug Administration. He will likely be confirmed in the full Senate.

Charleston, S.C.-based MUSC Health has deployed AI agents from healthcare software company Notable to automate 40% of prior authorizations without human involvement. What often took about 30 ...

“A large percentage of these Drugs, much of them in the form ... import taxes and duties. The change means that previously duty-free shipments now incur the new ten percent tariff, all prior ...

Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the companys aforementioned unit. The company will provide comprehensive response to US ...

This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation," Alembic Pharmaceuticals said in a regulatory filing. The company stated that it will submit a ...

“The Iraqi government is also working on diversifying gas import sources after signing a contract with Turkmenistan, as well as stopping gas flaring in Iraqi fields so that this gas can become the ...

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