Menu
Your search for “ ���� Cattle Ivermectin ���� www.Ivermectin-Stromectol.com ���� Guinea Pig Mites Ivermectin ���� Oral Ivermectin , Ivermectin Pi” returned the following results.
…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…
…touting silver-containing products, such as toothpaste, colloidal mixtures, and essential oils. The cited claims include: “[T]he patented Nano Silver we have, the Pentagon has come out and documented, and homeland…
…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,…
…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…
…a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it…
By Nisha P. Shah – On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed…
…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….
…products.” FDA’s announcement, which specifically covers oral extended-release, tannate, and immediate-release drug products, comes just one day after FDA denied (here, here, and here) three citizen petitions concerning marketed unapproved…
…treatment claims are also live and subject to judicial review, because, among other things, they are capable of repetition with other allegedly grandfathered products the companies manufacture and distribute (e.g.,…
…it chose to accept in vitro bioequivalence data for oral vancomycin (“bioequivalence claim”). The owners of the three approved ANDAs for generic oral vancomycin—Akorn, Incorporated (“Akorn”), Watson Laboratories, Inc. (“Watson”),…
…immunosuppressants, such as tacrolimus;” and (4) Require manufacturers of substitute oral formulations to “differentiate between strengths by color of capsule and container closure, to provide prominent dosage strength information, and to…
…Office of Criminal Investigation has investigated and been involved in the prosecution of Murray Rojas, a veteran horse trainer and non-veterinarian, who was indicted on allegations that, inter alia, from…
…OOPD several months later, in May 2006, with new information and clinical superiority arguments. But OOPD shot Hyperion down for a second time, in October 2006, saying, among other things,…
…quite broad. It includes “all labels and other written, printed, or graphic matter . . . accompanying such article,” 21 U.S.C. § 321(m), and could include brochures, leaflets, letters, and arguably…
…Act, and that FDA’s actions, findings, and conclusions in approving MITIGARE were arbitrary, capricious, an abuse of discretion, and without factual basis. In addition, Takeda wants temporary, preliminary and permanent…