FDA Related News

Covid Brought FDA Focus on Real-World Data: Report

A Bloomberg Law report says FDA is likely to place greater emphasis on real-world data in future regulatory decisions.

Human Drugs

FDA OKs Labeling Change on Heart Failure Device

FDA approves a labeling modification on Impulse Dynamics Optimizer Smart medical device, allowing the removal of a normal sinus rhythm limitation from...

Medical Devices

Machine Learning Principles for Device Development

FDA joins with Canadian and UK regulators to promote 10 guiding principles for good machine learning practice for medical devices.

Federal Register

Regulatory Review Period Determined for Xenleta

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Nabriva Therapeutics Xenleta injection (lefamul...

Federal Register

Regulatory Review Period Determined for Inrebic

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Impact Biomedicines Inrebic (fedratinib), indic...

Human Drugs

ICH Looking to the Future

The International Council on Harmonizations looks at changes it must make to evolve with the process of drug development in a changing healthcare syst...

Human Drugs

ElZarrad Named CDER OMP Director

CDER appoints M. Khair ElZarrad as director of the Office of Medical Policy.

Human Drugs

Advisors on Makena Must be Fairly Balanced: Public Citizen

Public Citizen calls on FDA to ensure that the membership of an advisory committee considering whether Covis Makena should be withdrawn is fair and ba...

Human Drugs

Hulu Series on Oxycontin Hits Hard, Goes Easy on FDA

Hulu launches an eight-part series on the Oxycontin epidemic that graphically lambastes Purdue Pharma but soft-pedals FDAs enabling role.

Biologics

Routine Vaccine Inspections May be Challenge: GAO

The Government Accountability Office says FDA may be challenged in resuming routine surveillance inspections of vaccine and allergenic manufacturing f...