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Medical Devices

Phillips Resumes Making Defibrillators Under Consent Decree

FDA asks a federal court to lift portions of a consent decree affecting Royal Philips to allow the company to resume manufacturing and shipping extern...

Medical Devices

Enforcement Discretion on Remote Digital Pathology Devices

FDA posts a new guidance entitled Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Covid-19) Public Health...

Human Drugs

FDA Safety Alert on Off-label Chloroquine

FDA issues a safety alert on off-label hydroxychloroquine or chloroquine use for Covid-19 outside of a hospital setting or a clinical trial due to ris...

Biologics

Speed Covid Vaccine Approval Process: Representatives

35 House members ask FDA and HHS to find ways to speed Covid-19 vaccine development and deployment.

Medical Devices

FDA Guidance on Medical Imaging Products for Covid-19

FDA issues an immediately-in-effect guidance to help increase the availability and capability of medical imaging products needed in diagnosing and tre...

Federal Register

Info Collection on Electronic Import Entries

Federal Register notice: FDA sends to OMB an information collection revision for Imports and Electronic Import Entries.

Human Drugs

2 Warning Letters on CBD Product Marketers

FDA issues Warning Letters to two companies for illegally selling unapproved products containing cannabidiol that violate the Federal Food, Drug and C...

Human Drugs

Stop Using Hydroxychloroquine at VA: DeLauro

Rep. Rosa DeLauro says the VA should stop using its stores of hydroxychloroquine on Covid-19 patients given scientific guidance that there is no safe ...

Federal Register

Info Collection on Drug Supply Security

Federal Register notice: FDA sends to OMB an information collection revision for drug supply chain security collections.

FDA General

Tobacco Product Premarket Deadline Extension OK

FDA says the Maryland federal court has approved its requested extension to 9/9 the deadline for manufacturers of some tobacco products that were on t...