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…whether supply chain disruptions are leading to specific bottlenecks, shortages, anti-competitive practices, or contributing to rising consumer prices.” The recent section 6(b) orders were sent to Walmart Inc., Amazon.com, Inc.,…
…6 months of pediatric exclusivity (until June 2, 2013). FDA, following the explanation provided in the Agency’s March 27, 2012 Letter Decision, [http://www.hpm.com/pdf/blog/SEROQUEL%20-%20FDA%20Letter%20Decision%203-27-2012.pdf] primarily argued that the scope of 3-year…
…those sites are in what CDER terms the “No Application” sector, meaning that those sites make over the counter (OTC) products, unapproved drugs, and homeopathic products, all sold without premarket…
…formulary tiers and subject to prior authorization, step therapy, or other coverage and reimbursement restrictions. Under the discount program, Medicare Part D patients with a valid prescription are able to…
…organization comes out with a report saying another thing supported by other data. In what appears to be a hastily drafted counterpoint to a report released earlier this week…
…at *1-*2 (E.D.N.Y. 2004) (same). So, for those companies out there with pending ANDAs and 505(b)(2) NDAs containing a Paragraph III certification that converts to a Paragraph II certification upon…
…trigger its 180-day exclusivity (which might not happen through commercial marketing because of the company’s manufacturing problems), and for which Ranbaxy qualified as a result of the company’s Paragraph IV…
…reimport drugs from Canada, and Sen. Jim DeMint’s (R-SC) Amendment No. 763 to prevent FDA from using funding to phase out by 2012 OTC epinephrine metered dose inhalers that contain…
…agreements”) filed with the Commission during the last fiscal year (Fiscal Year 2012): “Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of…
…drug and cosmetic is also subject to COPA’s requirements for cosmetics. Under federal, as well as California law, a cosmetic may be combined with an over-the-counter drug without the cosmetic…
…be viewed by industry. Since the 2004 Warner-Lambert settlement, the federal government has investigated hundreds of companies for promotion of approved products for unapproved uses, commonly known as “off-label promotion.” …
…data is frequently used by pharmaceutical companies in targetting physicians for detailing and other marketing activities. Vermont argued that it had enacted the Prescription Confidentiality Law (Vt. Stat. Ann., Tit….
…hydrocodone combination products would require patients to see their doctor for office visits with greater frequency simply to refill a prescription,” and “[a]s FDA could imagine, such a policy change…
…reproductive toxicity, and hormonal effects, are missing. Comments are due October 28, 2015. FDA explains that it provides a longer comments period (i.e., 180 days) because of the complexity of…
…since before the enactment of the 1938 FDC Act. In 1995, FDA concluded as part of its Over-the-Counter (“OTC”) Drug Review for PEPs that OTC PEPs are not generally recognized…