FDA Related News

Medical Devices

Azar Overruled Hahn on Covid Test Jurisdiction: Politico

Politico reports exclusively that HHS secretary Alex Azar ordered FDA to stop evaluating laboratory-developed tests over the objections of commissione...

Human Drugs

Public Workshop on Drug Integrated Assessments

FDA announces a 10/30 virtual public workshop on New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing ...

Medical Devices

Software Pre-Cert Program Far from Operational: Report

SheppardMullin attorneys say FDA seems to be years away from implementing its pilot software pre-certification program.

Medical Devices

Class 1 Recall on Alaris Pump Syringe/PCA Modules

FDA classifies as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due to potential incorr...

Biologics

CBER Lists 29 Guidances in CY 2020 Agenda

An updated CBER guidance agenda for 2020 lists 29 planned guidances in four categories.

Medical Devices

GEs Shatterproof Bulk Package for Contrast Agent OKd

FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clar...

Human Drugs

Comments on IND Communications with FDA

Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communications.

Trust Down for FDA, Drug Companies: Poll

Axios/Ipsos poll respondents say they have little faith in FDA or the drug industry to be looking out for the publics interests.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Kalchem International, Mayons Pharmaceuticals and Silkprousa.

Marketing

False, Misleading Claims in Sprout Addyi Radio Ad: OPDP

FDA warns Sprout Pharmaceuticals about a violative radio ad for Addyi, indicated for women with low sexual desire.