…‘Point-of-Care’ and ‘OTC Home Use’ are substantial. Devices authorized for Point-of-Care are not validated to the same degree with respect to Robustness (Flex Studies), Human Factors (Human Usability), the data…

…exceeding a limit of $75,000 for a single person plus $25,000 for each additional person. While patients with any government or commercial insurance are eligible for the free drug program,…

…experiences. In addition, cigar products may also contain various non-tobacco ingredients that the manufacturer uses primarily or exclusively for non-flavoring purposes (e.g., humectants, preservatives, adhesives), but could nonetheless affect the…

As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X…

…will need FDA approval. Thus, drawing the line is critically important. A low risk IVCT is one that: (A) would cause minimal or no harm, or minimal or no disability,…

…to drug approval user fees (PDUFA and GDUFA user fees) until they transition: The Federal Register Notice explains that FDA “does not anticipate that the identification and transitioning of products…

A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at…

…a scientific/medical matter, there are many variables beside the RAS device that are responsible for clinical outcomes. Will FDA now begin reviewing various types of manual surgical tools based on…

…even when a meeting has been scheduled. We have also noticed, in some circumstances, Offices declining to answer all of a sponsor’s questions noting that, for example, a separate pre-submission…

…than the market prices charged by local pharmacies. Filling controlled substance prescriptions at inflated cash prices also demonstrates that a pharmacy “has knowledge that it is filling prescriptions that are…

…to encourage value based arrangements in Medicaid New regulations to implement the alternative rebate for line extensions, including definitions of “new formulation” and “oral dosage form” A new, difficult hurdle…

…trial design, this type of intended use provides two opportunities to identify an individual as positive. Although FDA still requires that a test labeled for serial use achieve a minimum…

…surgeries associated with minimal tissue injury and mild postoperative pain (for example, dental extraction), dental pain, kidney stones, and headaches including episodic migraines. Clinicians should maximize use of nonopioid pharmacologic…

…estates on expensive brand-name drugs, even when those challenges could have been successful or resulted in favorable settlements. The net effect will be that brand-name prices will remain higher for…

…upon weight, and therefore might not be entirely used for a lighter weight patient. Currently, a health care provider identifies any discarded quantity from such a vial in the claim…