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…advertise on AdWords were accredited through its Verified Internet Pharmacy Practice Sites (“VIPPS”) program. According to the Agreement, the VIPPS program conducts site visits as part of the its certification…
…HCT/P should have been subject to notice-and-comment rulemaking is without merit since the statements were only in the rule’s preamble and not part of the rule itself. A fuller discussion…
…first, which was posted on FDA’s web site earlier this week, was a draft guidance on how a drug, biologics, or device manufacturer should respond to unsolicited requests for off-label…
…publicly-available scientific information or Agency knowledge about how a disease progresses to determine whether indications for use to treat a certain disease or anatomical site constitute a new intended use.” …
…be used in the labeling are moot.” FDA never finalized the draft guidance, and, in fact, removed the draft guidance from its website after receiving adverse comments. We understand that…
…clear you We will, we will, clear you Back by popular demand, coming to a collection site in your town for one day only, is a return of the ever…
…new rules, many LDT users may be forced to begin preparing for regulation when a final rule is issued. Bottom line – in the proposed rule, FDA asserts that it…
…discussed the proposed rule from May 2010 here. Issued nearly two years later, the Final Rule serves as an important guide for marketing drugs and drug-related products at all VA…
…scheduled to take place on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET. From routine on-site inspection to rummaging through trash bins outside your facility, FDA and other…
…an institution to review, approve the initiation of, and to conduct periodic review of biomedical research of human subjects) maintains continued oversight of clinical trials at a research site. However,…
…scheduled to take place on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET. From routine on-site inspection to rummaging through trash bins outside your facility, FDA and other…
…with respect to the rule. Whether the proposed rule concerning the induction of buprenorphine via telemedicine (see below) should be combined with the general telemedicine rulemaking. Telemedicine Prescribing of Buprenorphine…