FDA Related News

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 ...

Human Drugs

Genetic Metabolic Diseases Panel Established

Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic Metabolic Diseases ...

Medical Devices

Medfusion Syringe Pump Recalled Over Software

Smiths Medical ASD recalls its Medfusion model 3500 syringe pump due to software-related issues that can cause the device to fail to deliver therapy.

Human Drugs

sNDA for Ozempic Planned for Kidney Disease

Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing progression of kidney i...

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...