South Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical manufacturing capacity. South Korea continues to drive the effort in the biohealth…

As part of a larger COVID-19 outbreak response effort, many state pharmacy regulators have issued waivers or temporary suspensions of certain pharmacy laws. The California State Board of Pharmacy, State…

…https://www.mddionline.com/news/510k-statistical-patterns. [12] FDA, Third Party Review Organization Performance Report (version 1 of FY2022, Q4), at 38, https://www.fda.gov/media/162658/download?attachment [13] See id.; FDA, Performance Report to Congress: Medical Device User Fee Amendments…

On April 5, 2018, the Institute for Justice (IJ), on behalf of South Mountain Creamery (South Mountain), filed a complaint against the U.S. Food and Drug Administration (FDA) in the…

…the government alleged that eBay sold pill presses and counterfeit dies to hundreds of buyers. Also, DEA and DOJ contend, eBay did not verify purchaser’s identification as required by the…

…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….

…once Google became aware of the government’s investigation in 2009, Google required online pharmacies to engage the National Association of Boards of Pharmacy to certify that online pharmacies seeking to…

…Canada, S. 469 would amend FDC Act § 804 to direct FDA to promulgate regulations facilitating the importation of “qualifying prescription drugs” from “certified foreign sellers” in Canada and other…

…at 62,341. DEA precedent has evolved to define corresponding responsibility as requiring a pharmacy to resolve red flags before filling a prescription: “[A] pharmacist or pharmacy may not dispense a…

…this ruling particularly noteworthy. The Court of Appeals affirmed the FDC Act misdemeanor convictions of Joseph Gellerman, who worked as a store clerk for the business run by one of…

…membrane-release technology and rely on the size of the pill to control the release of the medication.”  As such, “[t]he generics subject to this litigation achieve peak concentrations in two…

…as opposed to Active Pharmaceutical Ingredients) from Canada, by traveling to Canada and purchasing drugs in pharmacies there, or by mail order, either through Internet websites or through telephone purchases. …

…from Canada into the United States. Drugs imported under a SIP must be approved by Health Canada and meet the conditions in an FDA-approved new drug application (NDA) or abbreviated…

…“FDA may determine whether any new labeling is reasonably necessary” and that “if the FDA actually believes that there is any significant difference between the one- and two- pill products,…

…the House would double prison sentences and triple fines for “pill mill” operators.  “Pill mills” are clinics, doctors’ offices or pharmacies that dispense or prescribe powerful opioids for other than…