WASHINGTON — House Speaker John Boehner sharply criticized President Barack Obama for resuming diplomatic relations with Cuba yesterday, calling it “another in a long line of mindless concessions” to the Castro dictatorship that has run Cuba since 1959.
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In a draft guidance published December 4, 2014, the Food and Drug Administration (FDA) has attempted to remove, at least in part, a legal hurdle that had created challenges for generic drug companies: Acquiring the samples of brand name products required to perform the bioequivalence studies that are the linchpin to the generic drug approval process, as well as other analytical comparisons required for submission and approval of an Abbreviated New Drug Application (ANDA).
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Lawmakers sometimes get a bad rap for not doing what their constituents want. But, even if you disagree with their politics or policies, you might find them helpful at times.
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U.S. Rep. Steve Stivers' legislation to rename two central Ohio U.S. Postal Service branches in memory of fallen soldiers awaits the signature of President Barack Obama.
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COLUMBUS, Ohio -- Gov. John Kasich said Tuesday his efforts to help get states to support a balanced budget amendment to the U.S. Constitution are an attempt to make the federal government more fiscally responsible before it is too late.
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FDA has issued a guidance document that details how generic-drug makers can obtain product samples from brand-name drug manufacturers for product testing. The guidance, titled “How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protocols Contain Safety Protections Comparable to Applicable REMS for RLD,” comes on the heels of criticisms that FDA does not help facilitate competition among manufacturers.
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The U.S. Senate voted this week to re-name London’s post office, located at 25 S. Oak St., for all local residents killed in the nation’s conflicts.
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Manufacturers are one step closer to gaining certainty on whether they will be faced with unnecessary regulatory hurdles simply for structuring in an efficient way to manage business risk.
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WASHINGTON — President Barack Obama delivered on his vow to halt deportation efforts and provide work permits for as many as 5 million undocumented immigrants yesterday, but by doing so he has provoked a monumental struggle with congressional Republicans.
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