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…Boards, National Association of Chain Drug Stores, Cardinal Health, CVS Caremark, Rite Aid and Walgreens met twice late last year to discuss these important, sometimes conflicting, issues. The stakeholders will…
…Department of Veterans Affairs (“VA”), and the Office of National Drug Control Policy (“ONDCP”) as well as practitioners, pharmacists, and other experts. The Act also requires HHS, along with other…
…of analysis. o If, however, a drug is compounded using ingredients other than bulk substances, then those ingredients must comply with USP/NF monograph, if applicable, and USP chapters on compounding (including…
…Under Section 503B of the Federal Food, Drug, and Cosmetic Act Case-by-case No 12/28/16 Draft Guidance (Comments due February 27, 2017) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies…
…effective prescription drugs—here, opioid analgesics. If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available…
…of Takeda Global Research & Development Center, Inc.’s (“Takeda’s”) diabetes drug ACTOS (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg. Watson, through its Complaint and Motion for a…
…any approved methods of using the listed drug” (emphasis added). Second, “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use…
…18, 2009 ruling), and then denied Sanofi’s request for a stay. See Sanofi-Aventis, et al. v. Sandoz, et al., No. 3:07-cv-2762 (D.N.J. Jun 30, 2009). Sanofi promptly appealed the decision…
…271(e)(4)(A) inherently depends upon FDA’s compliance with those orders, even when, as here, FDA is not a party to a private patent infringement litigation. [(citations omitted).] AstraZeneca’s brief in the…
…identify, review, evaluate and report suspicious orders. Moreover, once a distributor has identified a suspicious order, they are obligated to report this order to DEA and, logically, should not fill…
…other developed economies (Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and United Kingdom). The HHS analysis found that, on average, the…
…the letter) “all records relating to any posting on Cafepharma.com related to the ENHANCE study, including but not limited to, names, addresses, phone numbers, and e-mail and internet protocol addresses…
…priority review voucher, the benefit is nothing to sneeze at. After all, companies pay hundreds of millions of dollars to obtain priority review stats. In fact, earlier this week, it…
…like hepatitis, C, HIV/AIDS, opioid use disorder, and diabetes. The Plan also supports legislation to allow states to apply the Medicaid Drug Rebate Program requirements to bundled drugs provided as…
…or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support,…