On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). FDA believes that this final rule will improve its ability to identify potential drug shortages and to prevent or mitigate the impact of these shortages.
Continue Reading FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.

The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection.
Continue Reading FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to

Congressional committees continue to focus on the experience of consumers and insurers since the HealthCare.gov insurance portal launched on October 1, along with potential issues related to the security of personal data transmitted through the site. For instance, House hearings this week include an Oversight and Government Reform Committee hearing on “ObamaCare Implementation: The Rollout

On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) on appropriate uses of the custom device exemption identified in section 520(b) of the FDCA. By way of background, FDASIA amended section 520(b) of the FDCA, to (among other things) establish criteria for a device to qualify for a custom device exemption. Under section 520(b) of the FDCA as amended, “custom devices” are exempted from performance standard or premarket approval requirements if (among other things): (1) the device is “created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing)”; (2) the device is not “generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”; (3) the device’s purpose is to treat a “unique pathology or physiological condition that no other device is domestically available to treat”; and (4) the device is manufactured for the “special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of the physician or dentist (or other specially qualified person so designated)” or by an individual patient named in such order. Manufacturers are limited to using the custom device only for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impracticable.” Additionally, production of the device must be limited to no more than five units per year of a particular device type. Lastly, under section 617 of FDASIA, manufacturers will be required to submit an annual report explaining their use of the custom device exemption.  Additional details are available after the break.
Continue Reading FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation