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…a disease claim,” 65 Fed. Reg. 1000, 1022 (Jan. 6, 2000). However, Tuesday’s medical food Draft Guidance interpreted the statute’s prohibition on using the “Rx only” term on non-prescription drugs…
…the “approved organization” standard under the final rule will be similar. For example, at least 4 states (i.e., Indiana, Iowa, North Dakota, and Wyoming) require WDDs to hold NABP “Drug…
Earlier this year, North Dakota enacted a prescription drug price transparency reporting law, HB 1032, that became effective on August 1, 2021. (See our summary here.) This new law requires…
…benefits provided by drug and device manufacturers. Advisory Opinion 15-11, posted today, involves a manufacturer’s short-term free-drug program. The other, Advisory Opinion 15‑07, which was posted in June, concerned a…
…with an annually updated list of sales representatives who market the manufacturer’s prescription drugs to Nevada-licensed, -certified, or -registered HCPs, pharmacies, medical facilities, or individuals licensed or certified under the…
…the compound, FDA considers the compound to be a copy of a commercially available drug. FDA, Draft Guidance at 7, lines 250-59. FDA uses as an example an injectable drug…
…and, (3) stakeholders’ perspectives on how DEA enforcement actions have affected prescription drug abuse, diversion, and access to drugs for legitimate medical needs. To conduct its study, GAO administered web-based…
…recognized that compliance with postmarketing submission requirements poses unique difficulty for “real time” communications (e.g., blog posts, comments on a website, and twitter feeds), namely, the requirement that the firm…
…Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. 15, 2016. We blogged on the draft guidelines on October 12, 2015 and December…
…that the compounded drug is intended to address; If there are approved drugs for the condition, why the compounded drug from the bulk substance is necessary, supported by relevant literature;…
…open to the public; (2) price concessions and direct sales to hospitals, clinics, and physicians, except for inhalation, infusion, or injectable drugs, or except as determined by CMS; and (3)…
…user fees. Thus, for such companies, FDA’s costs remain static while the total amount of fees paid by the company continues to grow, eventually leading to an overage. The FDA…
…8126. Under the latter statute, manufacturers of “covered drugs” (generally, prescription drugs approved under a new drug application) must, in order for their outpatient drugs to be federally reimbursed under…
…possible, however, that with the prospect of paying a backlog fee, ANDA sponsors will withdraw some pending ANDAs before October 1, 2012, thereby decreasing the ANDA backlog andincreasing the per-ANDA…
…Columbia, August 6, 2010 (“Complaint”) at 3, 5. FDA’s Complaint states that the Regenexx Product is a drug under the FDC Act as it is intended to cure, treat and…