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…the close of business on January 24, 2014. Commenters submitting in the initial comment period may respond to comments from other commenters, and must submit those responses to FDA by…
…in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), essentially shielding generic drug manufacturers from liability because of the FDC Act’s same labeling requirement, is inapplicable to a generic drug…
…from Otsuka’s counsel, FDA changed course, alleges Otsuka, for an “improper extra-legal reason”: to prevent a result that would bar generic competition. According to Otsuka: On February 24, 2015, FDA…
…challenge exclusivity for generic drugs does not block approval of subsequent applications from other generic drug manufacturers until a first applicant begins commercially marketing the drug; this revision should ensure…
…this phrase means by way of examples. Specifically, a 510(k) is required if the proposed device: has a “different” intended use as compared to the generic device type; or uses…
…what the typical ANDA “fact board” looks like, here’s what our Generic COPAXONE 40 mg/mL “memory board” looks like: On January 28, 2014, FDA approved a supplement to Teva Pharmaceuticals…
…part of Commissioner Gottlieb’s Drug Competition Action Plan, designed to address competition and pricing in the generic drug market. It’s clear that this endeavor is a priority for Commissioner Gottlieb,…
…explorer 5. Beat handily 9. Tally at the end of an Advisory Committee 14. _____ Pharmaceuticals (recently acquired Dublin-based company) 15. Year: Lat. (NOTE: Mea culpa. This clue was changed…
…an ongoing effort and is well beyond the scope of the particular Guidance. If naloxone were available for OTC use, the patchwork of state standing orders would no longer be…
…id. § 1301.45 (“The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register . . . .”). DEA administrative hearings…
…proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the…
…test components, set technical specifications for each step of an NGS-based test, and document the limitations of each component for critical factors. The draft guidance identifies several specific test design…
…it possesses “competent and reliable scientific evidence” which the Order defines as at least “two adequate and well-controlled human clinical studies” substantiating the representation. The Order specifies that these studies…
…issued). It stated that it would “order coercive incarceration if a complete recall [was] not completed.” In August 2014, the Court found that Defendants did not complete the ordered recall. …
…patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin). Heeding the court’s order, the PTO granted the second interim PTE. The long-running dispute over a PTE for the ‘404 patent, which…