FDA Related News

Medical Devices

Medical Device RWE Guidance

FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evidence for regulatory...

Human Drugs

Merck Cholesterol, Cancer Drugs Added to Voucher Program

FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...

Human Drugs

FDA Warns Catalent Indiana for CGMP Lapses

FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations after investigators fo...

Human Drugs

Change Premarin Prescribing Info to Include Equilin: Petition

Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hormone equilin that is...

FDA Agentic AI Deployment Raises Concerns

Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues with information tha...

Human Drugs

GSK Long-Acting Biologic Approved for Asthma

FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.

Human Drugs

FDA Denies Akebia Reconsideration Petition

FDA denies an Akebia Therapeutics 2019 petition for reconsideration seeking five-year new chemical entity exclusivity for its Auryxia.

Human Drugs

FDA Easing Drug Approval Standards: Column

A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.

Microvascular Tissue Marketing Unapproved New Drug

FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...

FDA General

FDA Commissioner Defends Vaccine Stance, Transparency Push

In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...