Search Results for drug imports

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Democrats Propose Wide-Ranging Bill to Lower Drug Costs By Zachary Brennan - Published 30 March 2017

House and Senate Democrats late Wednesday offered up a host of new provisions to bring down the rising cost of pharmaceuticals, many of which have been publicly opposed by the pharmaceutical industry.

Categories: News, US, FDA, Government affairs, Manufacturing, Research and development

Tags: drug prices, Medicare drug negotiations, drug imports, drug exclusivity, FDA regulations

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike By Zachary Brennan - Published 14 February 2017

Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices

Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016) By Nick Paul Taylor - Published 09 February 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, TGA, Biologics and biotechnology, Business Skills, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Research and development

Tags: Indian drug imports, CFDA, TGA, drug tariffs, cancer guidance

FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs By Zachary Brennan - Published 07 December 2015

Arizona and Texas continue to battle with the US Food and Drug Administration (FDA) over the legality of importing drugs used in executions, more than two years after a Court of Appeals said the agency cannot allow the imports.

Categories: News, US, FDA, Communication, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Reimbursement

Tags: execution drugs, FDA drug imports, lethal injection imports, death row

What FDA Can and Can’t Do to Help Lower Rising Drug Prices By Zachary Brennan - Published 18 November 2015

Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: FDA, drug pricing, Robert Califf, Bernie Sanders, drug imports, ANDA backlog, generic drugs

Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US By Zachary Brennan - Published 14 September 2015

As part of its efforts to protect the drug supply chain, the US Food and Drug Administration (FDA) is implementing a final rule that will allow it to destroy a drug valued at $2,500 or less that has been refused entry into the US under federal law.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: final rule, FDA imports, FDA destruction of drugs, drug destruction, illegal drug imports