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…295 days (“Tier 2” goals). The review of a PMA is completed if the agency issues an approval order, an approvable letter, a major deficiency letter, a not approvable letter,…
…FDC Act, under which exclusivity is patent-by-patent, thereby giving rise to the possibility of shared 180-day exclusivity. That is, where there are, for example, two Orange Book-listed patents for a…
…“Rogue Pain Clinics” & “Pill Mills,” Prescription Drug Awareness Conference, May 4-5, 2013, unnumbered slides. However, if the American Medical Association (“AMA”) adopts either of two committee resolutions at its…
…here), Zogenix first sued Massachusetts Governor Deval Patrick and other Commonwealth officials after the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, took actions to combat…
…inapplicable regulatory provision on timing. Then, in its second letter, the agency claimed the clinical-superiority hypothesis was in fact required by virtue of still another regulation, although that rule, too,…
…National Drug Control Policy. The report will require feedback from patient groups, pharmacies, drug manufacturers, common and contract carriers, hospitals, state attorneys general, law enforcement, insurance providers, and drug distributors. …
…this fact by letter dated February 12, 2010. The completed NDA was then submitted on April 19, 2010, which is considered to be the NDA initially submitted date. Boehringer alleges…
…not apply to certain fish imported from Vietnam, which, although not “catfish” as defined by the FDC Act, apparently are often marketed as such. Three years later, the Farm Bill…
…cited the past decisions of T.J. McNichol, M.D., 77 Fed. Reg. 57133, 57146 n.18 (Sept. 17, 2012), and CBS Wholesale Distributors, 74 Fed. Reg. 36746, 36749 (July 24, 2009), in…
On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order…
…Masters Pharmaceutical, Inc. v. Drug Enforcement Administration, 861 F.3d 206 (D.C. Cir. 2017), where the court set forth new and significant suspicious order monitoring and reporting requirements, the industry still…
…summary quarterly reporting of malfunctions, unless they are in class III, in class II but permanently implantable, life supporting or life sustaining, or excepted from quarterly reporting by FDA in…
…clearly overbroad, and compliance would, as a practical matter, be unreasonable. Second, it ruled that the subpoena, without more, cannot substitute for a search warrant and alienate Signature from property…
By Susan J. Matthees – Two consumers, a resident of Florida and a resident of New Jersey, have filed a putative class action against Basic Research LLC, Carter-Reed Company, LLC,…
…Federal Circuit also ordered Pfizer and Mylan “to respond, no later than 10 a.m. on Monday, March 26, 2007, concerning how the invalidity determination affects the pediatric exclusivity period and…