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The combination of a closely split Senate, a Republican president and an upcoming presidential election in 2008 will likely add up to gridlock in the nation's capital, numerous experts say. Read More
Calling the impact of recent regulatory amendments to Canada’s drug patent rules “unnecessary and costly to taxpayers,” generic drug manufacturers led by the Canadian Generic Pharmaceutical Association (CGPA) are calling on a federal court to repeal modifications to federal regulations that provide brand manufacturers with eight years of freedom from generic drug competition. Read More
The FDA is looking into ultimately moving to an all-electronic submission system for regulatory information in all its divisions and will hold a public hearing on the proposal next month. Read More
The FDA will hold a Dec. 11 public meeting to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory.
A new subcommittee within the HHS Secretary’s Advisory Committee on Human Research Protections will develop recommendations on research protections for people with impaired decisionmaking capability starting early next year.
A new subcommittee within the HHS Secretary’s Advisory Committee on Human Research Protections will develop recommendations on research protections for people with impaired decisionmaking capability starting early next year.
Device and drug manufacturers should not take the somewhat vague language in federal regulations to mean they can get away with perfunctory, "checklist"-style GMP training, according to an expert speaking at a recent FDAnews audioconference.
A coalition of drug wholesalers will soon seek an injunction in federal court to delay the implementation of the FDA’s long-awaited drug tracking program, contending the new requirement will devastate their businesses.
The FDA is changing its generic drug review policy, abandoning its “first come, first served” approach when there is a potential public health risk to ensure that these submissions are not delayed, the agency said.
The SEC has notified Inspire Pharmaceuticals that its staff will recommend bringing civil action against the company and two executives for alleged violations of securities law.