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…NDA No. 022253 (tablets; approved on October 28, 2008), NDA No. 022254 (intravenous solution; approved on October 28, 2008), and NDA No. 022255 (oral solution; aproved on April 20, 2010). …
…regulations, or some combination of both. In any event, according to press reports, the expectation is that Wyeth will resolve these cases before Pfizer takes over Wyeth later this year….
…begin at 8:00 A.M. The meeting is open to all interested persons, including law enforcement, ultimate users (i.e., patients and members of their households), pharmacies, manufacturers, distributors, reverse distributors, or…
…1,213 days until December 4, 2011. The ‘507 patent was originally scheduled to expire on August 8, 2008. On March 16, 2005, FDA approved two NDAs for Astellas’s MYCAMINE: NDA…
…‘business day’ means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.”. (b) APPLICABILITY.—The amendment made by subsection (a) shall apply to…
…non-misleading speech concerning Vascepa, going so far as to detail, in its complaint, certain off-label promotional content regarding Vascepa that the Company proposed to disseminate. Early in the litigation proceedings,…
…Last week, amicus briefs were filed by the Solicitor General, the Generic Pharmaceutical Association (“GPhA”), several state attorneys general, and the International Trademark Association. The SG’s brief and the GPhA…
…formulated to incorporate physical or chemical barriers, agonist/antagonists, aversive agents, or combinations of two or more of these technologies (but not products in the delivery system, NME/prodrug, or novel approaches…
…And, indeed, FDA approved Teva’s ANDA No. 77-344 in April 2008 after expiration of a 30-month stay, presumably recognizing shared 180-day exclusivity. In September 2010, however, FDA converted Teva’s final…
…Substance Thefts From Pharmacies During Inventory, U.S. Attorney’s Office, Northern District of New York (Sept. 29, 2022), at https://www.justice.gov/usao-ndny/pr/company-pays-158760-resolve-claims-related-controlled-substance-thefts-pharmacies. Affiliated companies RGIS LLC (“RGIS”) and Retail Services WIS Corporation (“WIS”)…
…ABA’s “Blawg 100 Amici” website and nominate FDA Law Blog! Thank you! (It will only take a couple of minutes. Remember, when you complete the nomination form, our URL is www.fdalawblog.net.)…
…documents are due June 1, 2010, and can be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, rm. 1060, Rockville, MD 20852 or electronically at http://www.regulations.gov….
…things. (And no, warning letters are not clarification!) One solution is complete involvement. Have someone monitor the discussion, and, where appropriate, correct off label comments and other inappropriate discussions. They…
…new web development and design that facilitates interactive information sharing, such as social-networking sites (e.g., Facebook, Sermo), video-sharing sites (e.g., YouTube), wikis (e.g., Wikipedia), podcasts, blogs, and micro-blogs (e.g., Twitter). …
…tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the guidances “will be made final as soon as possible after public comment, and will be…