…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 amend the FDC Act to require labeling updates for new safety information for animal drugs, to allow for REMS for animal drugs, to require postmarketing studies for animal drugs…

…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…

…Circuit clarified the definition as: to “entice or persuade another person to take a certain course of action” (internal brackets omitted). Contrary to Pfizer’s contention that the term implies a…

…FDA makes no promises here of increased enforcement now that the Final Rule is out; in fact, the Agency states that it “intends to apply existing practices for monitoring the…

…confidentiality. Specifically, Vanda alleges that FDA communications to certain generic competitors regarding dissolution rates, impurities, and micronization revealed Vanda’s confidential manufacturing information and caused economic injury to the company. To…

…CMC challenges for CART therapies, including potency assay development, analytical method transfer, and demonstrating comparability. Panelists also provided advice and recommendations on how they approach potential these challenges as well…