FDA

Perrigo appoints Keith Webber head of regulatory review

Monday, September 23, 2013 09:46 AM

Perrigo has appointed Keith Webber head of regulatory review, effective Oct. 21. This new role will have responsibility for advancing the approval of all of Perrigo's Consumer Healthcare (CHC) and Prescription Pharmaceutical (Rx) regulatory applications pending with the FDA, providing guidance on scientific and regulatory strategy for new CHC and Rx pipeline products under development and continuously advancing the quality of new regulatory applications. 

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HeartWare receives FDA approval to enroll supplemental patient cohort

Friday, September 6, 2013 03:12 PM

The FDA has approved an IDE Supplement for HeartWare International, an innovator of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, to commence enrollment in an additional patient cohort for ENDURANCE, the company's Destination Therapy clinical study.

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John Hopkins study suggests neurologists unaware of drug risks

Friday, August 16, 2013 10:41 AM

A study by Johns Hopkins researchers shows a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

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Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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FDA, EMA approve C-Path’s simulation tool for Alzheimer’s trials

Friday, July 12, 2013 02:16 PM

Both the FDA and the EMA have independently reached favorable decisions on the value of independent nonprofit Critical Path Institute’s (C-Path) new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease (AD).

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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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