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FDA Related News

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Medical Devices

CDRH Patient and Caregiver Connection Program

CDRH sets up a Patient and Caregiver Connection program to obtain feedback from these stakeholders on their experiences living with a condition or usi...

Medical Devices

Contact Lens for Pediatric Myopia Slowing Approved

FDA approves CooperVisions MiSight, the first contact lens indicated to slow the progression of myopia in children between the ages of eight and 12 ye...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 11/15/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Proposal to Withdraw 4 NDAs

Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required...

Federal Register

OTC Drugs Panel Charter Renewal

Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years.

Federal Register

Info Collection on Device Q-Submission Program

Federal Register notice: FDA sends to OMB an information collection extension for Q-Submission Program for Medical Devices.

Federal Register

Info Collection for Radiation Product Testing

Federal Register notice: FDA seeks comments on an information collection extension for Testing Communications on Medical Devices and Radiation-Emittin...

Human Drugs

Generics See Mixed Results on Obtaining Samples: GAO

A new Government Accountability Office report finds that generic drug companies are having mixed results from FDAs efforts to help them get timely sam...

Human Drugs

Panel Backs Expanded Vascepa Use

FDAs Endocrinologic and Metabolic Diseases Advisory Committee unanimously votes to recommend approval for Amarins submission to expand Vascepas (icosa...