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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...

Medical Devices

Cagent Vascular Serranator Balloon Catheter Cleared

FDA clears a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee lesions.

Human Drugs

Temporary Propofol Repackaging, Combining Guidance

FDA publishes a temporary policy on repackaging or combining propofol general anesthesia products to help ease a shortage during the Covid-19 public h...

Human Drugs

Steps to Data Integrity Compliance

ProPharma Group lists steps drug companies can take to best handle planned and unplanned internal and external inspections.

Medical Devices

Support for Reclassifying HIV Tests

Four stakeholders say they support an FDA reclassification of some HIV tests to Class 2 with special controls.