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…any potential harm to the government, and (4) it is in the public interest for agencies to comply with the law and Medicaid beneficiaries to obtain access to local pharmacies….
…Healthcare Provider” letters to hospital Directors of Pharmacy/Administrators and to those healthcare providers who directly purchase/prescribe ESAs and ensure access to communication materials online. The most onerous part of this…
…of substantial equivalence. Given the implications of receiving an NSE for cybersecurity alone, manufacturers and interested parties can still provide comments online regarding the draft guidance until May 13, 2024….
…does not distinguish between the inorganic and potentially harmful forms of arsenic and the organic and essentially harmless forms). The letter closed with a strong admonition: “The FDA believes that…
…of the Center for Devices and Radiological Health, stated that “[u]sing complex medical devices at home carries unique challenges … Caregivers may lack sufficient training, product instructions may be inadequate…
…Center Director, after which the appeal may be taken to the FDA Commissioner. In reviewing use of the scientific resolution procedures and applicable regulations, OIG used the following sources: “CDRH…
…verify a purchaser’s date of birth by means of photographic identification. The results of FDA’s compliance checks can be accessed online in a database that is searchable by retailer name…
…will complement Ms. Walsh’s former experience at FDA. They will discuss what can be learned from recent settlements involving medical product advertising and promotion. FDLI’s annual Advertising & Promotion conference…
…within the app itself. The guidelines suggest that app developers follow these “truth-in-advertising” practices: Objective claims made in or about your app must be supported by “competent and reliable evidence.” …
…Agency. FDA also remains committed to ferreting out counterfeit drugs in the national drug supply. In that vein, Lieutenant Commander Christl stated that FDA recently sent letters to practitioners and…
…or has reason to know’ that the prescription is invalid.” Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,341 (Oct. 12, 2012)…
…whose commercial package bears a label containing the symbol “Rx only”, the legend “Caution: Federal Law Prohibits Dispensing Without Prescription” or “Caution: Federal Law Restricts This Drug To Use By…
…Larry Larkin. The Complaint alleges that defendants were dispensing, and billing Medicare for, prescriptions in violation of the Controlled Substances Act and the False Claims Act. The Complaint also alleges…
On June 6, the Eleventh Circuit vacated the Federal Trade Commission’s (“FTC’s”) data security-related cease and desist order against LabMD, Inc. (“LabMD”), a diagnostic testing company. The decision was less…
…unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products, the court commented: By their very nature, plaintiffs’ claims cannot be evaluated as a question of pure law. An enforcement action brought on…