AiCure

Ethics/Regulatory

U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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vfa CEO responds to German pharmaceutical policy changes

Monday, March 3, 2014 12:46 PM

The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code, including an extension of the drug price freeze to 2017.

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U.S., India sign cooperation statement

Thursday, February 27, 2014 12:24 PM

According to the Press Information Bureau of the Indian government, the FDA and India’s Ministry of Health and Family Welfare have signed a Statement of Intent on Cooperation in the Field of Medical Products.

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EMA, FDA collaborate on medicines safety

Friday, February 21, 2014 03:31 PM

The EMA and FDA, which respectively regulate drugs in the E.U. and U.S., have announced a new pharmacovigilance “cluster” to provide a forum to share information on the safety of medicines.

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Regulatory update on India clinical research approval timelines

Wednesday, February 5, 2014 01:26 PM

Dr. Renu Razdan, vice president, ACRO India, and also chief operating officer, CRO Max Neeman Medical International, said he welcomes the new timelines and guidelines set up by the Drug Controller General of India [DCGI] for approval of clinical trials.

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Report: EMA finds increase in rare disease medicines

Monday, February 3, 2014 10:19 AM

A total of 11 out of 81 medicines recommended for marketing authorization by the EMACommittee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of rare diseases. This continues the year-on-year increase in the number of marketing authorization recommendations for medicines for rare diseases observed over the last few years (with eight in 2012 and four in 2011).

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New Breakthrough Therapy Designation shows potential to shorten drug development time

Wednesday, January 29, 2014 01:04 PM

The Breakthrough Therapy Designation (BTD) program, launched nearly 18 months ago by the FDA and aimed at expediting development and review of drugs intended to treat a serious condition, has the potential to shorten development time considerably, according to the Tufts Center for the Study of Drug Development (Tufts CSDD), which recently completed an assessment of the BTD program.

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FDA launches advisory committee membership nomination portal

Wednesday, January 22, 2014 12:56 PM

The FDA has launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees. 

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EMIG welcomes Parliamentary inquiry into NICE

Monday, January 6, 2014 11:52 AM

The Ethical Medicines Industry Group (EMIG) has welcomed the House of Commons Health Select Committee's inquiry into the National Institute for Health and Clinical Excellence (NICE). This is an opportunity for the SME specialist biopharmaceutical sector to reflect on the workings of the medicines regulator, in particular its future role in supporting the new commissioning environment and how the value of innovative new medicines will be assessed.

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Regulators, HTA dialogue key to medicines development

Tuesday, December 3, 2013 08:30 AM

“A strong interaction between regulators and health technology assessment bodies (HTAs) is critical to enable innovation to reach patients, and ultimately for the benefit of public health,” said Guido Rasi, executive director of the EMA.

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CWWeekly

November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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