FDA Related News

Human Drugs

FDA Approves Sandoz Prolia, Xgeva Biosimilars

FDA approves Sandoz Jubbonti and Wyost, the first interchangeable biosimilars for Amgens Prolia and Xgeva.

FDA General

Budget Compromise Gives FDA $160 Million Boost

Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boos...

Medical Devices

1st OTC Continuous Glucose Monitor Cleared

FDA clears a Dexcom 510(k) for the companys Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose mon...

Federal Register

Info Collection on FDA Drug Communications

Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications as Used by the Food...

Human Drugs

Bell Intrnatl. Labs Warned Over CGMP Violations

FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.

Human Drugs

CGMP Violations Found at Colgin

FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.

Medical Devices

QS, MDR Violations at Fresenius Kabi Facility

FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Ivenix Infusion System.

Human Drugs

New Dietary Ingredient Notification Guidance

FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.

Comments on FDA Guidance Best Practices

Four stakeholders respond to an FDA request for comment on guidance best practices.

Human Drugs

Follow Laws Intent on Drug Innovation: Scott, Carter

Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match congressional intent in ...