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Guidance on REMS Testing During Virus Outbreak

FDA releases a guidance entitled Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 3/20/2020.

FDA General

Since Our last Issue...

Industry news you may have missed since our last issue.

Federal Register

FDA Permanently Debars Kalinoski on Filthy Drugs

Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending ...

Federal Register

Tighe Permanently Debarred by FDA

Federal Register notice: FDA permanently debars Gerald Tighe from providing services related to an approved or pending drug product application.

Federal Register

Edwards Permanently Debarred by FDA

Federal Register notice: FDA permanently debars Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pendi...

Human Drugs

2 Guidances on Making Hand Sanitizers

FDA issues two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer products.

Medical Devices

FDA Clears Remote Monitors Temporary Expanded Use

FDA issues a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for healthcare providers to ...

Some Adverse Event Reporting Relaxed Under Pandemic

FDA issues a guidance entitled Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic that outlines circ...

Human Drugs

FDA Update on Painkillers Worsening Virus

After gaining some media attention, a new FDA safety update says it is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, ...