…how many comments were actually logged in; on December 7, FDA showed 19,655 comments, and the next day 6,732.) While some comments were boilerplate, others were comprehensive, detailed critiques of…

…180-day, real-time or panel track supplement to FDA; and For Health Canada, specify if it represents a new or significant change amendment Class III or IV submission to Health Canada….

…Horton’s from Canada. On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was…

…are favorable compared to those in Canada, while many brand-name drugs are much less expensive in Canada than in the United States.  FDA initiated legal action against one chain of…

…in July 2019 (see our coverage here). The NPRM describes “Pathway 1” which will allow for the importation of certain prescription drugs from Canada. The Draft Guidance sets forth “Pathway…

…Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 384, to allow states and other entities (Sponsors) to develop a Section 804 Importation Program (SIP) to import certain prescription drugs…

…would provide savings to commercial health insurance customers. For 17 prescription drugs, VAHS determined that importation from Canada could result in annual savings between $1 and $5 million. However, VAHS…

…process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones…

…of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 384, to allow for the importation of certain prescription drugs from Canada. Under the Final Rule, states…

…tribes to get over before actually being able to import prescription drugs from Canada. After the SIP proposal submission, FDA must first authorize the SIP proposal. From there, the state/tribe…

…on the prescription with all other required elements at the time the practitioner signs the prescription. For an emergency oral prescription, the prescribing practitioner must communicate the information to the…

…under 13; and Companies that have actual knowledge that they are collecting PI via another company’s website or online service that is directed to children. If a company is covered…

…Vermont Agency of Human Services (VAHS) to design a wholesale prescription drug importation program that complies with federal drug importation laws (21 U.S.C. § 384), including requirements for safety and…

…There were a few presentations that included research and data on how consumers read disclosures online, and the innovative techniques that some companies are creating to effectively communicate disclosures (including…