News

Latest News | 14 May 2013

Legislators Launch Investigation into Resignation of Prominent FDA Official

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Republican legislators on the House Energy and Commerce Committee announced on 13 May 2013 that they are opening an investigation into the unusual and unexpected departure of one of the US Food and Read More...

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Latest News | 5 December 2012

CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

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It’s that time of year—the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no Read More...

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Latest News | 20 November 2012

Report Claims Staffing Problems Continue to Plague FDA

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The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts Read More...

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Latest News | 14 September 2012

Legislators Slam DHHS, FDA for Special Hiring Practices

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The US Food and Drug Administration (FDA) has increased its use of special hiring authorities more than 50% in recent years to bring on staff members who can be paid more than the normal limit for Read More...

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Latest News | 22 August 2012

Top FDA Regulatory Official Stepping Down, Will Assume New Duties

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The US Food and Drug Administration’s (FDA) top regulatory affairs official, Dara Corrigan, is giving up her duties and assuming a position as director of FDA’s Europe Office and as senior advisor for Read More...

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Latest News | 1 May 2012

CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal Read More...

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Latest News | 25 April 2012

Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees

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Health Canada is facing the prospect of dire budget cuts after national austerity measures called for more than $5.2 billion to be cut from the Canadian federal budget, reports The Globe and Read More...

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Latest News | 3 April 2012

New FDA Standard on Cargo Theft Released

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The US Food and Drug Administration (FDA) released a new standard operating procedure (SOP) for staff outlining how FDA responds to cargo thefts.The 23 March SOP, FDA'S Response to Cargo Thefts, Read More...

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Latest News | 23 March 2012

BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

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An article in The British Medical Journal (BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai’s blockbuster Alzheimer’s drug Aricept 23 (donepezil) despite Read More...

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Latest News | 7 March 2012

Study of FDA Staff Scientists Finds Lingering Concerns Amidst Improving Outlook

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A study released 7 March by the Union of Concern Scientists (UCS) finds that US Food and Drug Administration (FDA) staff scientists are increasingly upbeat about the direction of the agency.Among the Read More...

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