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…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)…
…also interesting from a procedural standpoint. At least some of the questions in the web posting may have originally been included in an Advanced Notice of Proposed Rulemaking (ANPRM) that…
…almost every area of enforcement that CDER undertakes. One of 12 offices at CDER, a look at its annual report tells us a great deal about CDER’s enforcement priorities. Led…
…FDA bring together “all industry stakeholders” to work together on the issue. For its part, FDA has already issued a public statement on the IOM report, and stated that it…
Our fellow bloggers over at The Volokh Conspiracy recently posted an interesting story concerning a congressional investigation into Merck/Schering-Plough’s cholesterol absorption inhibitor VYTORIN (ezetimibe; simvastatin). We previously reported on, among…
…health and is stepping up its efforts. In its December 15, 2010 letter, FDA asks the industry for support in its efforts. The allegedly illegal active ingredients do not ordinarily…
…relationship must exist for a doctor to issue a prescriptions in the usual course of professional practice and that the doctor must have conducted a physical examination to establish such…
…are on LinkedIn, and Facebook (but no, we’re not friending all of our readers). (We also have a neat Web 1.0 website.) But one new social media tool leaves us,…
…as well as in physician offices, clinics, hospital inpatient and in-clinic services and upon request. The communication plan will consist of letters to Nephrology and Oncology related professional societies, “Dear…
…of the Center for Devices and Radiological Health, stated that “[u]sing complex medical devices at home carries unique challenges … Caregivers may lack sufficient training, product instructions may be inadequate…
By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health is conducting a usability study of the establishment registration and device listing database. The objective is to make…
…the least burdensome requirement as well as the concept of substantial equivalence. Given the implications of receiving an NSE for cybersecurity alone, manufacturers and interested parties can still provide comments…
…of an interim report, titled “Authorized Generics: An Interim Report,” presenting the first set of results from an FTC study conducted at the request of several members of Congress to…
…external stakeholder groups . . . said it was too early after implementation of the Rule to have data on its effects.” Nevertheless, industry stakeholder report consumer interest in hearing…
By Ricardo Carvajal – It almost escaped our notice – a blog posting by FDA asserting that “there is currently no evidence to suggest a public health risk from fruit…