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…during the mark-up session, including provisions concerning over-the-counter hearings aids, requiring risk-based device inspections, restricting drug imports . . . . and, of particular interest to this blogger, provisions creating…
…1, 2014), in which the then-Deputy Administrator made a finding based on his own “internet search” on the California medical board’s website without taking official notice—or providing the respondent with…
…reasonably foreseeable interactions do not cause incorrect operation of other networked systems; and conduct[ing] testing that simulates real-world use of the device.” The final guidance indicates that label*]}*ing considerations with…
…annual aggregate cash compensation in an amount equal to Twenty Five Thousand dollars ($25,000). FDA notes this point in Footnote 1 of the Warning Letter, calling out the video and…
…that an October 2003 warning label other than approved by the FDA would have been in direct actual conflict with Federal law.” In contradiction, it is plaintiff herein who supports…
…numbers for all of the categories in the table above, and then breaking out some of the categories (by number or percent). The historical Orange Book data show some interesting…
…the fifth straight year that FDA labs found an increasing level of noncompliance. Table: Laboratory Sample Compliance Rates by Fiscal Year Conclusions OPQ faces increasingly global challenges as it seeks…
…various non-clinical testing in the development or manufacturing process. Effect on FDA approvals—In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid…
…of the tactics used to promote NEURONTIN for “off-label” uses, the August 29th ruling also provides a good overview of one judge’s description of the law concerning “off-label” drug use. …
…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…
…line between an OTC hearing aid and an OTC self-fitting hearing aid would allow hearing aids that do require “self-fitting” to be sold as “non-self-fitting” without clinical testing and conformance…
…You can access the conference brochure and sign up for the event here (or by emailing customerservice@americanconference.com or by calling 1-888-224-2480). We look forward to seeing you at the conference….
…patent, including the April 2007 PTO decision, can be found on the PTO’s Patent Application Retrieval Database by searching by patent number. While the PTO was considering The Medicine Company’s…
…and guidances Litigation and compliance updates Safety label*]}*ing changes: real world execution into packaging, advertising, and promotion Engaging payors, nontraditional, and emerging customer markets Advocacy groups: when & how should…
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…