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…Tablets, 0.6 mg, and Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively “Elliott”), entities with investment interests in COLCRYS, in a dispute stemming from FDA’s September 26,…
…regular orpan drug approval, such as FDA’s recent approval of IMPAVIDO (miltefosine) to treat leishmaniasis (resulting in the third Tropical Disease Priority Review Voucher) (see here). No, we’ve tended to…
…Phase III trial may fail in material ways.” “If so, perhaps Sandoz will not file for approval, thereby eliminating altogether the patent dispute it has asked the district court to…
…in November 2013, in Sandoz Inc. v. Amgen Inc., Case No. 3:13-cv-02904-MMC (N.D. Cal.), the U.S. District Court for the Northern District of California granted Amgen’s Motion to Dismiss a…
By Ricardo Carvajal – That’s the clever title of a symposium on entomophagy being delivered at the next annual meeting of the Entomological Society of America (ESA), scheduled for the week of…
…initial release has been marred by numerous problems pertaining to data accuracy and the lack of information about the potential benefits that can arise from relationships between the drug and…
…questions from external stakeholders. The FDA Draft Information Sheet emphasizes unique considerations for informed consent of certain vulnerable populations, including: Careful consideration of ethical ramifications of enrolling or excluding potential…
…be accompanied by a cover sheet disclosing that FDA has not reviewed the data and any financial interests between the study author and the manufacturer. The reprint also must be…
…of scientific information from an accompanying reprint. Firm-generated communications must meet the general recommendations in the Draft Guidance and “should be truthful, non-misleading, factual and unbiased and provide all information…
…Tobacco Control Act. Last week, the agency issued the much anticipated proposed deeming regulations that would cover electronic cigarettes (“e-cigarettes”), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and…
…Hatch-Waxman Amendments contain incentives to reward the development an approval of novel drugs, these particular products already have been developed and approved. Recognizing additional exclusivity in this case is not…
…developments to expect in 2014. In addition, panelists will analyze pressing compliance issues, including regional warning letters and off-label promotion issues. This conference will cover hot topics in the medical…
By Bill Koustas & Alan Kirschenbaum – In July, we reported that Massachusetts had amended its prescription drug and device marketing law to (among other things) allow pharmaceutical and medical…
…care program antikickback law, the Federal False Claims Act, and other federal and state fraud and abuse laws and related laws, identifying noteworthy cases and OIG precedents that interpret these…
…comes too soon because Plaintiff is just beginning the determinative phase of the clinical trial process and many uncertainties remain as to if and when Plaintiff’s alleged biosimilar will ever…