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…combined total of the advisory review and operating reserve fees established by FDA. Based on industry’s interest in participating in the program, it seemed that the program would commence. FDAAA…
…prohibit the refilling of Schedule II prescriptions. DEA’s final rule amends the regulations to allow individual practitioners to issue multiple prescriptions authorizing patients to receive “a total of up to…
Earlier today, FDA issued a Federal Register notice announcing the Fiscal Year 2008 user fee rate for advisory review of Direct-to-Consumer (“DTC”) Television advertisements for prescription drug and biological products. The…
…generic products, lower prices, and savings to Federal, State and local governments, private employers and individual consumers of more than $200,000,000,000 per year. Specifically, the bill provides that notwithstanding the…
…PET drug produced by that establishment will be used within the medical center itself. Although FDARA does not place all PET drug sponsors on equal footing with therapeutic drug sponsors…
…count criminal Information. They were also placed in home detention for six months, required to complete 100 hours of community service, and ordered to pay a total of $150,000 in…
…and effective digital health products. One step in the plan is developing a Digital Health Software Precertification (Pre-Cert) Program. We blogged on the overall digital health plan here. As part…
…Annual Report provides some consolidated petition numbers from FYs 2008-2012. According to FDA, the Agency has received a total of 116 petitions subject to FDC Act § 505(q). The annual…
…days of the due date will result in the several consequences, including that all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the…
By Kurt R. Karst – A recent report issued by Morgan Stanley, titled Pharmaceuticals – Potential Selective Upside for Industry post Prandin Ruling, predicts “increasing probability for the innovative pharmaceutical…
By Jeffrey N. Wasserstein & Alexander J. Varond – Several months ago, when HHS released the final HITECH rule, we noted that several of the provisions represented a sea change…
…2010 combined, and the total amount of credits/grants that may be allocated among certified projects may not exceed $1 billion for the two-year period. Applications must be submitted during a…
…one-year interim patent extensions (thus, a total of five years). The PTO may also extend (either on its own initiative or upon the application of a patent owner) the term…
…processes were unduly burdensome and time-consuming and were preventing technological advances from reaching patients. The case was not a total loss for FDA. As noted above, the court did find…
…as a tentative approval, and withhold final approval of any NDA supplement for LOTREL. Pfizer’s petition for stay of action requests that FDA stay the approval of any LOTREL NDA…