FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Change Premarin Prescribing Info to Include Equilin: Petition

[ Price : $8.95]

Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hor...

FDA Agentic AI Deployment Raises Concerns

[ Price : $8.95]

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

GSK Long-Acting Biologic Approved for Asthma

[ Price : $8.95]

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

FDA Easing Drug Approval Standards: Column

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Commissioner Defends Vaccine Stance, Transparency Push

[ Price : $8.95]

In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency ac...

Makary Says No Plans for Covid Vaccine Boxed Warning

[ Price : $8.95]

FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report fr...

3D Imaging CGMP and Listing Violations

[ Price : $8.95]

FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of posi...

FDA Extends Review Timeline for Aldeyras Dry Eye Drug

[ Price : $8.95]

FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investig...

Guide to Increase Female Enrollment in Trials

[ Price : $8.95]

FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.