Ethics/Regulatory

Industry groups want to be heard on the impact of sunshine law before new regulations are finalized

Monday, May 16, 2011 09:36 AM

The so-called sunshine law, which requires drug sponsors to publicly disclose payments to physicians and teaching hospitals, will present significant operational challenges to biopharmaceutical companies and contract research organizations (CROs) when data collection requirements go into effect in January 2012. However, industry groups worry their concerns about how the law could affect clinical research won’t adequately be taken into account as the rule and its regulations are finalized during the next four months.

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Chile's plans to create drug regulatory agency

Monday, May 9, 2011 01:10 PM

The Chilean parliament will examine legislation for a national medicines agency, which is good news for global drugmakers, according to Pharma Times.

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Biotechs say FDA regulations impede job creation

Friday, April 22, 2011 12:13 PM

Drug and medical device companies are having a hard time creating jobs and delivering innovative new therapies to patients because of tight government regulations, limits in science and research funding and high taxes reported biotech industry leaders at a recent congressional hearing in San Diego, according to The San Diego Union-Tribune.

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Anulex Techonologies will layoff workers

Wednesday, April 20, 2011 11:28 AM

Minnesota-based Anulex Techonologies will layoff workers after receiving a warning letter from the FDA in February, 2011, according to Fierce Medical Devices. 

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U.S. government threatens to bar Forest CEO

Friday, April 15, 2011 12:27 PM

U.S. officials have sent a letter to Forest Laboratories chief executive Howard Solomon threatening him with a ban from participating in Medicare and Medicaid, according to Pharma Times.

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Government shutdown could force FDA to cut staff

Friday, April 8, 2011 11:16 AM

Officials working with the FDA warned that the looming government shutdown will severely restrict food and drug inspections, according to a CNN Money report.

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Pharmas eagerly await FDA guidance on social media

Thursday, April 7, 2011 11:01 AM

As the FDA further delays its eagerly-awaited draft guidance on social media, U.S. drugmakers have pointed to the "incredible potential public health benefits" of using electronic media in health care, according to Pharma Times.

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Family medicine residencies reject pharma relationships

Tuesday, March 29, 2011 10:28 AM

Family medicine resident programs in the U.S. have limits on drug industry interaction with doctors, and several shun doctor-company relationships altogether.

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Drugmakers may face FDA fines for slow efficacy confirmation in cancer drugs

Monday, March 28, 2011 01:04 PM

Winning early U.S. approval of promising cancer treatments could wind up costing drugmakers up to $10 million in fines if they don’t confirm their drugs’ effectiveness in follow-up studies within a restrictive timeframe, FDA officials said, according to a Bloomberg report.

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FDA requires sponsors to inform study volunteers that clinical trial information will be posted online

Monday, March 28, 2011 08:05 AM

The FDA has issued a final rule requiring drug developers to include in informed consent paperwork the disclosure that clinical information from the trial will be entered onto ClinicalTrials.gov.

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