The acronym REMS stands for Risk Evaluation and Mitigation Strategy, a component of approval that may be required when the FDA determines that additional information beyond prescribing information is necessary to ensure that the benefits of a drug outweigh its risks....
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Proposal for Modernizing the 510(k) Program Appears Controversial
Proposal Comment Period ExtendedOn April 11ththe FDA extended the comment period for call for comments on how to shift industry and agency focus towards the development and use of more modern predicate devices for determinations of Substantial Equivalence (following...
Cybersecurity is a Concern for the FDA
In case you haven’t noticed, cybersecurity for medical devices is a subject of concern for the FDA. The issue has been clarified this week by the announcement of cybersecurity vulnerabilities affecting Medtronic Implantable Cardiac Devices, Programmers, and Home...
Monitoring Clinical Trials for Drug Safety Issues
On March 21, 2019 the FDA issued an alert about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma. The alert is based on review of data from the Bellini clinical trial (NCT02755597, Study...
Facility Shutdown May Impact Supply of Medical Devices
Earlier this year, the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The...
CDRH is Reorganizing This Year
The FDA’s Center for Devices and Radiological Health (CDRH) is reorganizing this year to better integrate the center’s premarket and postmarket program functions and optimize decision making across the total life cycle of medical devices. The new organization will be...
New Guidances to Broaden Cancer Trial Eligibility Criteria
The FDA’s Oncology Center of Excellence (OCE) in cooperation with CDER and CBER has released several new guidances intended to broaden the eligibility criteria for cancer clinical trials. A trial’s eligibility criteria define the patient population studied in the...
Draft Guidance for Food Effect and Bioavailability Studies
This February CDER issued draft guidance for clinical studies on the effects of food administration on and bioavailability of orally administered drug products. The bioavailability guidance also applies to drug products where systemic exposure measurements are...