…metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses)….

By William T. Koustas –       Earlier this month, FDA announced that Institutional Review Board (“IRB”) Coast IRB, LLC of Colorado Springs, Colorado (“Coast”) voluntarily agreed to stop reviewing new FDA-regulated…

…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…

…to offer the qualifying product at a “reasonable price” (as defined in the bill) and to publicly disclose all pre-clinical and clinical trial data relating to the product, the award…

…Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for…

…supplemental clearance or approval is that it allows them to augment the device labeling with an additional use. FDA’s speech restrictions go beyond this quid pro quo to apply criminal…

…do so if it were to recur. We blogged about some aspects of the problem here. It is astonishing that FDA has flouted the law for ten years, and almost…

…the same question (although it was Question 7) as follows: “FDA recommends that audit trails that capture changes to critical data be reviewed with each record and before final approval…

…in Altamonte Springs, Florida, for manufacturing unapproved umbilical cord blood products in violation of current good manufacturing practice (CGMP) requirements, including failing to validate processes to prevent bacterial contamination, raising…

…defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult…

…in comments from the National Association of Attorneys General. All of this is the long way to say that Congress’s concern about delays in the issuance of a final rule…

…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…

…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…

…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.”  Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…

…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August  2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…