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By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal…
…of commercial websites or online programs that are directed to a general audience if the operator has “actual knowledge” that it is collecting, using, or disclosing PI provided by children…
…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’…
…eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants. Requiring Online Submission of Applications for and Renewals of…
…is there mention of possible referral to the Office of Chief Counsel or Office of Criminal Investigations for review of more egregious alleged misconduct, although several of the categories of…
…Canada, and New Zealand, and only to people over the age of 18. So far, so good. This is pretty basic, although other than ensuring that the entities are real…
…government healthcare programs for Gamunex. According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection…
…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones. Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…
…10. 21 CFR 870.5200 External cardiac compressor. 11. 21 CFR 870.5225 External counter-pulsating device. 12. 21 CFR 870.5310 Automated external defibrillator. 13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form)….
…extrajudicial punishment “code red” is authorized in various Marine handbooks, and Lt. Kaffee’s cross-exam of Cpl. Barnes. Here’s the script (you can view the video clip here): Capt. Ross: Corporal Barnes,…
…has actively and deliberately targeted a greater number of well-known, national brands. All advertisers under FTC jurisdiction are well-advised to review their use of online disclosures sooner rather than later. …
…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…
…a not-for-profit, global organization dedicated to bringing health care product development professionals together in a neutral environment to improve health and well-being throughout the world. The conference focuses on the…
…Performance Goals and Procedures Fiscal Years 2023 Through 2027). FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition…
…for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies. 21 U.S.C. § 823(f). The Act also established new definitions for “Internet,” “online pharmacy,”…