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…industry. As FDA’s own regulation makes clear, “[g]uidance documents do not establish legally enforceable rights or responsibilities” and “do not legally bind the public or FDA.” 21 C.F.R. § 10.115(d)(1). …
…of urea products in the OTC Drug Review. FDA has a long-standing regulatory compliance policy for OTC drugs under which the Agency generally defers action on products that contain active…
…to obtain labeler codes. This is significant as it codifies FDA’s current practice, which has been somewhat controversial. More on that in a bit. In addition to the requirements for…
…content” rather than the aforementioned “prohibited content.” Facebook’s restricted content policy for OTC drugs requires that the branded content “must comply with all applicable local laws, required or established industry…
…Fairness Act of 2013 (H.R. 3715) would allow Americans to buy prescription drugs from certain countries deemed to have comparable safety standards to the United States, including Australia, Canada, Israel,…
Colorado and Florida have joined Vermont in the list of states seeking to combat high prescription drug prices by establishing programs to import drugs from Canada. On April 29, 2019,…
…Canada will use for a biologic that is similar to an approved innovator biologic. In Canada these product are referred to as “Subsequent Entry Biologics.” By Kurt R. Karst …
…Congress.’” Arizona, 132 S. Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). Focusing on the Plaintiffs’ contention that the MPA Amendments violate the Supremacy Clause, U.S….
…in court. In one case – Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005) – a federal court concluded that a state plan for importing drugs from…
…that allow for the importation of certain drugs from Canada. The demonstration projects must be designed to comply with the federal drug importation laws outlined in Section 804 of the…
…obtain informed consent from research subjects. 21 C.F.R. § 50.20. However, it is typically the responsibility of the sponsor of an applicable clinical trial to post the information to www.clinicaltrials.gov. …
…sort by “ID number” to group dockets together. In Beta, you have to separately search “Documents” and “Comments.” That means running each search twice . . . . and reviewing…
…to waive into D.C. Bar). Compensation commensurate with experience. Excellent benefits package. Email resume to jwasserstein@hpm.com. For more information about the firm, see www.hpm.com. HP&M is an equal opportunity employer….
…receive a discount) at www.AmericanConference.com/Cosmetics, or contact Bolam Kim (B.Kim@americanconference.com) directly to attend. Please be sure to use discount code S10-866-866L16.S to register and receive 10% off the tuition fee. …
…a solution to companies that have discontinued ANDAs for drug products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com; and https://www.andarepository.com/) is offering what we can only characterize…