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First examined in Citizen's Insurance Co. v. Parsons (1881), Sir Montague Smith of the Judicial Committee of the Privy Council determined its scope thus: . The words "regulation of trade and commerce," in their unlimited sense are sufficiently wide, if uncontrolled by the context and other parts of the Act, to include every regulation of trade ranging from political arrangements in regard to ...
In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. [8] Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition. [8]
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; [40] however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only ...
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
The approval time for NDAs in the 8 years before the implementation of PDUFA I was roughly 31.3 months. During this period, the approval time exceeded 30 months in every year except 1990 when it was 27.7 months and 1992 when it was 29.9 months. From 1993 through 1996, the average approval time fell to 20.8 months.
In 2011, the American Medical Association recommended a uniform prior authorization form with real-time electronic processing. The proposed process would involve a physician ordering a medical service, their staff completing a standardized request form, and an electronic submission process with same-day approval or denial.
For a patent to be valid in Canada, the invention claimed therein needs to be new and inventive.In patent law, these requirements are known as novelty and non-obviousness.A patent cannot in theory be granted for an invention without meeting these basic requirements or at least, if a patent which does not meet these requirements is granted, it cannot later be maintained.
Name Ministry Dates 1. Jean-Luc Pépin: under Trudeau: April 1, 1969 November 16, 1972 2. Alastair Gillespie: under Trudeau November 27, 1972 – September 25, 1975