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Human Drugs

CDER Posts Revised Policy on Good Review Practices

CDER posts a revised Manual Of Policies And Procedures on the publication and use of good review practices within the Center.

Federal Register

Workshop on Animal Models for Serious Infections

Federal Register notice: FDA announces a 3/1 public workshop in Silver Spring, MD on the current state and further development of animal models for se...

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA General

Latest Federal Register Notices

FDA Review posts medical product Federal Register notices released the week ending 2/24/2017.

FDA General

Trump Orders FDA, Others to Form Reform Task Force

President Trump signs an executive order requiring FDA and other federal agencies to establish a regulatory reform task force, which will ensure that ...

Federal Register

20 New Animal Drug Approvals Withdrawn

Federal Register notification of withdrawal. FDA withdraws approval of 18 new animal drug applications and two abbreviated new animal drug application...

Medical Devices

Intersect ENT Propel Contour Sinus Implant Approved

FDA approves an Intersect ENT PMA for its Propel Contour steroid releasing sinus implant.

FDA General

FDA Aint Broke, Doesnt Need Fixin Pines

Writing under the headline FDA Aint Broke, Doesnt Need Fixin, former associate commissioner Wayne Pines urges the Trump Administration to heed industr...

Medical Devices

FDA Grants de novo Petition for Pheno System

FDA grants a de novo petition request to allow marketing of Accelerate Diagnostics Pheno system and PhenoTest BC kit for identification and antibiotic...

Human Drugs

OGD Reports Record Generic Approvals Last Year

A new blog post discusses CDERs Office of Generic Drugs record number of approvals in 2016.