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…revised rule also clarifies that national or regional DTC advertising expenses should be reported on a prorated basis. Such expenses are to be calculated by multiplying the total expenses by…
…according to FDA in a recent decision responding to a 2009 citizen petition submitted by Osmotica Pharmaceutical Corp. (“Osmotica”) involving Venlafaxine HCl Extended-Release Tablets. In May 2008, FDA approved Osmotica’s 505(b)(2)…
…or partially revoke its Federal Register notice announcing Food Safety Modernization Act (“FSMA”) user fees amounts because the fees were allegedly calculated in a manner contrary to the method specified…
…of course, Star Trek. I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun). I also remember the September 1987 premier…
…been included in warning letters issued for alleged violations of requirements applicable to seafood HACCP, acidified foods, food allergen labeling, animal drug residues, and sanitation and pest control (see, e.g.,…
…a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21. FDA’s Federal Register Notice for the hearing identified issues to be discussed that were careful to avoid…
…cannot cover any condition of approval for which “new clinical investigations” were not “essential.” If an earlier-approved drug product was approved for a particular condition of approval, new clinical investigations…
…well-controlled clinical study of a “low calorie meal replacement program . . . designed to lower the user’s total caloric intake” that follows “acceptable designs and protocols” or a protocol…
…complaints, including minor to major medical events, but also complaints about non-medical issues such as off-taste or color of a product. Information in the database includes demographic (e.g., age, gender)…
…protected by exclusivity when supported by new clinical investigations essential to the approval of the deletion (which it does not),” writes FDA, “in this case, the new clinical investigations that…
…that has frustrated us at times, sometimes causing a rift in the relationship, and delighted us at other times, bringing us closer together – is that some product listings are…
…whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological…
…Court for the District of Massachusetts seeking a judgment with respect to certain patents allegedly covering Janssen Biotech, Inc.’s (“Janssen’s”) biological product REMICADE (infliximab) (see our previous post here). Both…
…District of Massachusetts seeking a judgment with respect to certain patents allegedly covering Janssen Biotech, Inc.’s (“Janssen’s”) biological product REMICADE. The Complaint marks the beginning of the second lawsuit that…
…Finalization of the guidance document is intended to meet this FDASIA requirement. An eCopy is required for nearly all medical device submissions, including 510(k)s, de novo petitions, PMAs, IDEs, HDEs,…