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…power than the other? How should you prepare for each? Can you prevent an investigator from entering, or block them from access to areas not covered by a warrant? Can…
By Kurt R. Karst – The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate;…
…trial, conviction, and sentencing of Berkeley Nutraceuticals’ former in-house counsel Paul Kellogg. Mr. Kellogg’s conviction arose out of two distinct series of events – one that the government alleged was…
…FDA Law Blog FDC Act § 505(q) Citizen Petition Tracker. Osmotica’s May 30, 2008 citizen petition concerns FDA’s May 20, 2008 approval of Osmotica’s 505(b)(2) application (NDA #22-104) for Venlafaxine…
…an amendment to a pending ANDA should be categorized as major or minor. Under the GDUFA Performance Goals and Procedures, amendments can affect the goal date for action on an…
…position, we would have to accept the proposition that even partial inadvertence is sufficient. The electronic version of the Orange Book reflected the withdrawal of the ‘952 patent at least…
…Animal Drug User Fee Act (“ADUFA”) through Fiscal Year (“FY”) 2013, creates a new law for generic animal drug user fees (the Animal Generic Drug User Fee Act of 2008),…
…that addresses the safety of food, drugs, devices, and cosmetics as well as a number of general provisions relating to the agency. Although the draft may undergo significant change during…
…rules, personnel changes, new and improved policies, along with related issues such as healthcare fraud and abuse, drug and device reimbursement, and other topics of interest. Since then, we have…
…to expedite the approval of Abbreviated New Animal Drug Applications. Sponsors of innovator drug products currently pay user fees under the Animal Drug User Fee Act; Reinspection user fees to…
…of medical device-related subjects and provide an update on developments at FDA’s Center for Devices and Radiological Health. A copy of the brochure and registration form are available here. Additional…
…a broad range of topics (from personalized health care to import safety) that FDA Law Blog readers might find of interest. You can sign up for Secretary Leavitt’s blog here….
…of approved drug product dosage forms. Although FDA’s distinction between patents covering packaging and drug delivery systems is helpful in a very general sense, the Agency’s failure (or unwillingness) to…
…also prescribed for many off-label uses, however, including chronic idiopathic demyelinating polyneuropathy, also known as chronic GuillainBarré syndrome. There are currently two HCPCS codes for IVIG products, depending on whether…
…charity perspectives, advertising and promotion implications, adverse event reporting, and anticipated future developments. Hyman, Phelps & McNamara, P.C.’s Alan Kirschenbaum will moderate the program. Registration information can be found here….