FDA Related News

Stakeholders Comment on Digital Data Acquisition Draft

Stakeholders give comments and suggestions to FDA on its draft guidance on using digital health technologies for remote data acquisition.

Medical Devices

Comments on FDA Device Transition Guidance

Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 public health emergenc...

Human Drugs

FDA Approves Higher Dose of Ozempic Diabetes Drug

FDA approves a 2 mg dosage level of Novo Nordisks diabetes drug Ozempic.

Medical Devices

Staar Surgical Implantable Vision Correction Lens OKd

FDA approves a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia and myopia with astigmatism.

Human Drugs

FDA Questions Modest Benefit in ALS Drug

An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data contained in Amylyx ...

Federal Register

Device Rule Reduces Paper Copy Submissions

Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of cer...

Federal Register

Animal Drug Regs Amended for Approvals

Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbrev...

FDA General

Senator Scott Urges FDA to Fill Vacancies

Senator Rick Scott (R-FL) urges FDA to fill vacant management posts at CDER and CBER because FDA is too important an agency to operate under temporary...

FDA General

FDA Budget Request Seeks $2.1 Billion Spending Boost

FDA outlines a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of president Bidens just-released budget request, ...

FDA General

Bill Would Prevent Conflicting FDA Consultant Contracts

A Senate bill seeks to bar conflicts of interest in consulting contracts, such as those FDA signed with McKinsey & Co. on regulatory actions involving...