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…July 2023 and the U.S. launch would be in early 2024. How “accessible” will OTC naloxone really be? In announcing the approval, Commissioner Califf encouraged the manufacturer to make OTC…
…an OTC approval to retail shelves at long last. Sponsors have been unable to overcome the challenges of switching some widely used prescription drugs to OTC for a very long…
…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’…
…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…
…2001, FDA held a joint meeting of the Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees to consider the issue. Although the committees recommended the Rx-to-OTC switches of ALLEGRA, ZYRTEC, and…
By Riëtte van Laack – The Over-the-Counter (“OTC”) drug regulatory framework was established by FDA more than 40 years ago in the OTC Drug Review. The procedure was intended to…
…period occurred for commercial marketing or use” (emphasis added)), and if “the permission for the commercial marketing or use of the product . . . is the first permitted commercial…
…will give these companies to compete these post-authorization studies. The template closes with a final recommendation for labeling: Proposed labeling should clearly identify the population in which the test’s performance…
…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…
…in the repository. For each OTC monograph title (e.g., nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., M002) and an Order ID (e.g., OTC000001) and…
…embraced by non-prescription drug companies. This panel will analyze the recent high-profile switches shaping the OTC industry landscape, including: Opill Naloxone Explore what FDA has considered in approving the latest…
…U.S. labeling, including the following required labeling statement: “[This drug was/These drugs were] imported from Canada without the authorization of [Name of Applicant] under the [Name of SIP Sponsor] Section…
On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont. The new law directs the…
…element of the federal requirements, VAHS set forth to determine whether importing drugs from Canada could result in savings to Vermont consumers. Vermont Medicaid determined that importing drugs from Canada…
…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….