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…process.) eSTAR submissions are automated (e.g., form construction, auto filling). eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing.…
…automatic construction and auto-filling content; content and structure that is complementary to CDRH internal review templates; integration with FDA databases and guidance documents; and automatic verification. While eSubmitter is a…
…MDCO’s alleged unclean hands before FDA and in filing the patent infringement lawsuits. According to APP, MDCO “comes to these lawsuits with unclean hands that preclude MedCo’s requested relief,” because…
…asked to clarify this term. Are EPRs the same as “Essential Performance” as defined in IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential…
…to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight.” The Federal Register notice setting forth the special controls for this new class of devices was…
…rejuvenation devices, and holding a public meeting regarding gynecologic surgical mesh. These tools all appear to be ones that FDA can take under its current statutory authority to ensure safe…
…appealed the FTC ruling and order to the Eleventh Circuit. In its appeal to the Eleventh Circuit LabMD argued, among other things, that the FTC erred in finding that LabMD’s…
…LDTs: “1976-Type LDTs,” which FDA describes as “us[ing] manual techniques (without automation) performed by laboratory personnel with specialized expertise; use of components legally marketed for clinical use; and design, manufacture,…
…or “biological products” requiring an investigational new drug application (“IND”) or biologics license application (“BLA”) was arbitrary and capricious – Judge Daniel concluded that they, too, were not ripe because…
…public health and safety” by prohibiting the company from disseminating information about risks of serious adverse events to physicians already using Botox for this off-label use. Allergan attributes the overly…
…for commercial marketing or use.” The statute says nothing about the patentee actually or constructively receiving notice of the FDA approval. Hence, Applicant’s argument is not fully consistent with the…
…alternate FOP label scheme of their own choosing. Depending on the underlying rationale, such a restriction could invite a First Amendment challenge. An additional impact on industry could result from…
…panel judges quickly acted to request a poll of all the sitting Circuit judges with respect to the petition for rehearing en banc. It is also a good sign for…
…Care Component (“CPI Medical”) during the preceding calendar year or twice the CPI Medical during the preceding two years. Thus, under S.B. 539, manufacturers must choose how to forego their…
…reading of the congressional language and upsetting the basic economic bargain Congress carefully constructed. In explaining FDA’s regulations implementing the orphan drug exclusivity statute, the dissent asserted that such regulations…