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Medical Devices

Guide on Viral Transport Media Enforcement

FDA posts a final guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.

FDA General

Product Approval Summaries

FDA Review posts summaries for medical product approvals for the week ending 7/17/2020.

Medical Devices

Verathon Recalls GlideScope Video Cable

Verathon recalls the GlideScope Core One TouchSmart Cable due to the potential for temporary or complete loss of image when used with certain video mo...

Federal Register

FDA Science Advisors to Get Agency Tox Research Updates

Federal Register notice: FDA announces an 8/18-19 Science Advisory Board to the National Center for Toxicological Research meeting.

Federal Register

Guide on Real-world Data in Animal Drug Filings

Federal Register notice: FDA makes available a draft guidance entitled Use of Real-World Data and Real-World Evidence to Support Effectiveness of New ...

Federal Register

Lilly Latruvo BLA Approval Revoked

Federal Register notice: FDA announces it is revoking approval of an Eli Lilly BLA for Lartruvo (olaratumab), indicated for combination use with doxor...

Human Drugs

Warning Sent to Web Site on Unapproved Drugs

FDA sends a Warning Letter to the operators of www.pharmaboosters.com over marketing unapproved and misbranded drugs.

Medical Devices

FDA Clears Ambu Single-use Duodenoscope

FDA clears an Ambu 510(k) for its Ambu aScope Duodeno, a single-use duodenoscope.

Human Drugs

Denovo Bio Fast Track for Enzastaurin

FDA grants Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients with newly-diagnosed gl...

Human Drugs

Three Possible Foreign Inspection Outcomes Seen

Attorney Mark Schwartz outlines three possible scenarios to resolve the current pause in FDA foreign manufacturing facility inspections.