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A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled…
By Nisha P. Shah – Under a bill titled, “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law,” the State of Maine repealed three laws related…
…Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60) (L.D. 171) (West) (the “2013 Act”), went into effect on October 9, 2013, and…
…commerce wholly outside of Maryland. Compl. at 2, 23-27, AAM v. Frosh, No. 1:17-cv-1860 (D. Md. July 6, 2017). The Commerce Clause empowers Congress to regulate commerce “among the several…
…Gottlieb and HHS Secretary Azar. A proposed rule released today by CMS would require pharmaceutical companies to disclose wholesale acquisition cost (WAC) in TV advertisements for prescription drugs. The rule…
…Director of the Office of Compliance and Biologics Quality, as well as various offices within CBER and CDER on a variety of compliance issues involving medical products. Mr. Schwartz also…
…four types of possible victims in the alleged doctor/patient scheme: paying patients, non-paying patients, doctors and insurance companies, the latter which were not mentioned in the indictment as being defrauded….
…legal issues arising in these areas of technology. Each component chapter has a comparative introduction, looking at the variances in the laws of different domains, followed by side-by-side analysis of…
…the meeting in person, while others may join the meeting online; others may be entirely online. However, to the best of our knowledge, CDRH has not granted a meeting where…
…[are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov. A short-form warning for the same product could read: ⚠WARNING: Cancer – www.P65Warnings.ca.gov Not…
By Alexander J. Varond – Undoubtedly, most microbes in humans are nonpathogenic, if not beneficial (a.k.a., “good bacteria”). But, since at least the advent of the microscope, humans have shown…
…authorities, such as the EPA and the European Commission, which had concluded that glyphosate is not likely to be carcinogenic in humans. In fact, IARC was the only entity that…
…associated with diseases in humans, including pneumonia, skin and tissue infections, pelvic inflammatory disease, and serious gastrointestinal infections in children. As a result, treatment of these infections in humans with…
…pharmacy boards require pharmacies that engage in sterile human drug compounding to be in “full compliance” with the quality standards for sterile compounding set forth in USP<797>. An additional ten…
…MMA, 180-day exclusivity was triggered by the earlier of: (1) the first commercial marketing of the drug by a first filer; or (2) “the date of a decision of a…