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…two” that are being marketed as treatments for a variety of conditions, including “ear wax buildup, sinus infections, hearing loss, headaches, colds, flu, and sore throats.” Ear candling, also known…
…firm experience, including litigation experience, and a federal judicial clerkship. E-discovery expertise is a bonus. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send…
…“181 days after” after first-filer marketing); Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1284 (Fed. Cir. 2008) (same); Altana PharmaAG v. Teva Pharms. USA Inc., no….
We previously reported (April 25, 2007, May 22, 2007, August 14, 2007) on a trend in policing promotional and advertising claims by FDA’s Division of Drug Marketing, Advertising, and Communications…
…Tsujii, Nakamura & Partners, Japan Klaus Schweitzer, Plate Schweitzer Zounek, Patentanwaelte, Germany Deborah Somerville, Kenyon & Kenyon, USA Paul Steinhauser, Arnold Siedsma, Netherlands Nigel Stoate, Taylor Wessing, UK Rosie Stramandinoli,…
…ideal candidate will have experience working at FDA or with a medical device company, and prior big law firm experience is helpful. Compensation is competitive and commensurate with experience. HP&M…
…has be raised in some false marking cases (see, e.g., Hollander v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2-10-cv-00836 (E.D. Pa.), it has not, to our knowledge, previously been used as the…
…also claimed that Skechers made deceptive claims about its Resistance Runner, Toners, and Tone-ups shoes. See Complaint 12- 16, Federal Trade Commission v. Skechers USA, Inc., No. 1:12-cv-01214 (N.D. Ohio…
…Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius. In that case, a 3-judge panel of the D.C. Circuit (Judges Henderson, Griffith, and Williams) ruled in a…
…products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com) is offering what we can only characterize as “ANDA arbitrage.” Imagine, if you will, a parking lot. The owner…
…district court’s subject matter jurisdiction, and the Federal Circuit’s March 2007 decision in Teva Pharms. USA v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007), in which the Court,…
…petition for panel rehearing and rehearing en banc of the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius. In that case, a 3-judge panel of…
…FDA-regulated industries. Today, FDA Week, an industry publication from Inside Washington Publishers, ran an article (subscription required) reporting on FDA Law Blog’s recent post concerning 505(b)(2) application user fees. Also,…
…already existing and well-regarded DailyMed database. As a side note, FDA’s labeling website also includes information on OTC drugs, homeopathic drugs, unapproved drugs, and medical devices, with similar disclaimers that…
…approximately 2 p.m. EDT. The deadline to register for oral comment is 11:59 p.m. EDT, Aug. 15. https://www.ams.usda.gov/event/listening-session-organic-livestock-and-poultry-standards. Comments to the proposed rule may be submitted until Oct. 11, 2022….