Ethics/Regulatory

FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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FDA approves Lupin’s UltramR ER

Wednesday, August 31, 2011 01:04 PM

Lupin Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ERshortly.

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NIH finalizes changes in conflict of interest rules

Wednesday, August 24, 2011 02:12 PM

The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies, according to a report by the Washington Post.

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FDA creates modernization plan

Tuesday, August 23, 2011 12:43 PM

The FDA is prioritizing development of technologies to compare biosimilars to innovator products in its plan to modernize regulatory science.

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FDA approves first gene-targeted drug for Melanoma

Wednesday, August 17, 2011 12:05 PM

The FDA has approved Zelboraf, known as vemurafenib or PLX4032 during testing, well ahead of the approval deadline.  Zelboraf is the first drug to treat advanced melanoma by targeting a specific gene mutation.

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FDA issues guidance to improve clinical study quality

Monday, August 15, 2011 01:40 PM

The FDA has issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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Regulatory requirements become more complex as clinical trials increase

Friday, August 12, 2011 10:45 AM

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, experts have warned, according to PharmaTimes.

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BU professor fabricates data in two published experiments

Wednesday, August 10, 2011 11:43 AM

A cancer researcher and assistant professor at the Boston University School of Medicine Cancer Research Center fabricated data in two papers published in scientific journals, federal authorities announced, according to a report by the Boston Globe.

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Roche seeks compromise with FDA over Avastin

Monday, August 8, 2011 01:41 PM

In a bid to salvage the breast cancer indication for Avastin, Roche’s Genentech unit has pitched to the FDA what it is calling a “middle-ground proposal” that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide, according to Pharmalot.

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Merck receives subpoena regarding marketing and selling of drugs

Monday, August 8, 2011 01:34 PM

Merck has received a subpoena from the US Department of Justice as part of a criminal investigation into the marketing of various drugs. The feds want info about marketing and selling these drugs - Temodar, which treats brain tumors; the PegIntron hepatitis C treatment; and Intron A, which treats certain cancers - from 2004 through the present, according to Pharmalot.

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