FDA Related News

Human Drugs

Ferring Wants Restrictions on Firmagon Generics

Ferring petitions FDA to require in vivo testing for ANDA and follow-on applications citing the companys Firmagon as the reference-listed drug.

Medical Devices

Class 1 Recall of E25Bio Covid-19 Test

FDA classifies as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test because it has not been authorized, cleared, or approved by the ag...

Human Drugs

FDA Approves 1st Generic Drug Based on PBPK Model

FDA says it was able to approve a generic diclofenac sodium topical gel using an alternative method to determine bioequivalence.

Human Drugs

People Want More FDA Transparency: Survey

Johns Hopkins researchers say a survey of U.S. adults shows people want much more transparency from FDA.

Human Drugs

FDA Drug Expert Ellis Unger Joins Law Firm

After retiring from FDA last year, controversial former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger join...

Medical Devices

FDA Proposes Use of ISO Medical Device Standard

FDA releases its proposed rule to change the Quality System Regulation by incorporating an international standard.

CytoDyn Promoting Unapproved Drug: OPDP

The CDER Office of Prescription Drug Promotion warns CytoDyn that a video misbranded its investigational drug leronlimab by making promotional claims ...

Human Drugs

Toxicon Violated GLP Regulations: FDA

FDA warns Toxikon/Labcorp Bedford about violations of Good Laboratory Practice regulations in a clinical study.

Medical Devices

BASE10 Genetics Kit Recall is Class 1: FDA

FDA says the BASE10 Genetics recall of a sample collection kit is Class 1.

Human Drugs

CBD Qualifies as Old Dietary Ingredient: Petition

The Natural Products Association asks FDA to determine that CBD is recognized as a dietary ingredient.