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…a Complaint filed in June 2015 by Ferring Pharmaceuticals Inc. (“Ferring”) against FDA challenging the Agency’s denial of 5-year New Chemical Entity (“NCE”) exclusivity for Ferring’s PREPOPIK (sodium picosulfate, magnesium…
…judgement of the Federal Circuit. Agreeing with Judge Prost’s dissents in the Federal Circuit’s initial and rehearing decisions in this case, the Government argues that a generic’s label*]}*ing should not…
…cases are moving steadily towards resolution, though an appeal is likely in both no matter how the courts rule. (A third case – also involving infliximab and a Celltrion Complaint…
…are chemically and biologically identical might nonetheless bear different safety information, confusing patients and prescribers alike. The label*]}*ing on the generic products should be ide tical to the label*]}*ing on…
…consumers through the media or otherwise, other than by means of the tobacco product’s label, label*]}*ing, or advertising, after June 22, 2009, respecting the product that would be reasonably expected…
…publication of an “inflated” average wholesale price (“AWP”), marketing the “spread,” offering kickbacks to providers, and promoting the drug for off-label use. The complicated factual and procedural history of the…
…outcome of the case. The judge’s admonition to outside counsel is also worth noting. “Even if lead counsel was merely implementing directives from Boston Scientific’s in-house counsel, lead counsel ultimately…
…Regarding off-label and contraindicated use, Relator alleged that Medtronic marketed the devices without FDA clearance or approval for use in the cervical spine. Such use was both off-label and specifically…
…binding on persons or entities outside the Executive Branch (including state, local, and tribal governments).” The second, and arguably more significant, policy prohibited its lawyers from civilly prosecuting companies for…
…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones. Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…
…capriciously in rejecting petitioners’ PMTAs.” Going through “[f]our well-established and longstanding principles of administrative law,” the Court explained how any one of such principles “independently require that result.” Specifically, the…
…priority for 2022-2023 to advance health equity. He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care…
…demanding that FDA issue regulations that require the label*]}*ing of all food produced using genetic engineering. CFS filed the petition on behalf of the Just Label It campaign. Co-petitioners include…
…approved drugs violate the FDCA. Id. at 9. The court described FDA’s long-standing position that off-label promotion of drug products risks criminal misbranding under the FDCA. FDCA § 301(b). A…
…and research staff; Improving study participant awareness and knowledge of the clinical study (e.g., providing language assistance); Reducing participant burden (e.g., avoiding unnecessary procedures, imaging, and laboratory tests; employing sites…