FDA

FDA issues draft guidance for IRBs

Tuesday, November 27, 2012 11:28 AM

The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.

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Cetero reaches final resolution with FDA

Tuesday, April 24, 2012 03:10 PM

Cary, N.C.-based CRO Cetero Research has reached a final resolution with the FDA over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. Following months of open collaboration between Cetero and the agency, the FDA summarized its final decision:

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FDA issues new guidance on device approval

Tuesday, March 27, 2012 01:49 PM

The FDA has published its first guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

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FDA seeks $4.5 billion FY 2013 budget

Tuesday, February 14, 2012 11:56 AM

The FDA is requesting a budget of $4.5 billion to protect and promote the public health as part of the president’s fiscal year 2013 budget—a 17% increase over the FDA enacted budget for FY 2012.

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FDA issues draft guidance on biosimilar product development

Thursday, February 9, 2012 01:58 PM

The FDA has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the U.S.

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FDA’s CDRH sets goals for personalized medicine

Tuesday, January 24, 2012 02:51 PM

The FDA's Center for Devices and Radiological Health has set personalized medicine as one of its priorities for the current year, aiming for draft guidance on co-development of drugs and diagnostics by year's end.

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FDA includes social media in advertising guidance

Tuesday, January 24, 2012 02:45 PM

The FDA has issued a final guidance for industry product name placement, size and prominence in advertising and promotional labeling, including juxtaposition of proprietary and established product names.

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Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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FDA, ABIA collaborate on safety and performance of materials in medical devices

Thursday, December 22, 2011 11:05 AM

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