Whistleblowers to get reward for info on fake drugs in India | New U.K. committee aims to improve access to medtech specialist advice | Companies in Italy must register certain IVD medical devices in national database
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July 22, 2014
DIA Global SmartBrief
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Whistleblowers to get reward for info on fake drugs in India
The Indian Ministry of Health & Family Welfare has announced that it will give whistleblowers a reward of as much as 20% of the value of medicines seized if they provide information that leads to the seizure of counterfeit drugs. The Wall Street Journal (tiered subscription model)/Pharmalot blog (7/18)
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New U.K. committee aims to improve access to medtech specialist advice
The U.K. is creating the new independent Devices Expert Advisory Committee to increase its access to scientific expertise about device regulation. The DEAC will replace the Committee on the Safety of Devices and is expected to be more responsive and quick in obtaining advice on complex issues from the clinical community. Clinica (7/21)
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Companies in Italy must register certain IVD medical devices in national database
New rules require IVD companies operating in Italy to register their products in the Repertorio national database of medical devices in order to participate in public tenders. Products subject to the new rule include self-testing IVDs and such IVD tests as HIV, blood grouping and self-test blood glucose monitoring. IVD manufacturers hope that an imminent upgrade of the registration part of Eudamed, the European medical device database, will make the Repertorio unnecessary, according to the European Diagnostic Manufacturers Association. Clinica (7/21)
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Asia Pacific
Rules governing medtech studies, registrations issued in India
Regulators in India have released guidelines explaining the requirements for registering medical devices and conducting clinical trials in that country. The guidelines state, among other things, that approvals for device-related clinical studies, researcher accreditation, and ethics panel and site approvals will resemble those of drug-trial policies. MassDevice.com (Boston)/Emergo Group blog (7/18)
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India cuts prices of 440 essential meds
The Parliament of India was informed last week that prices of 440 essential drugs have been significantly reduced as of June 30. The National List of Essential Medicines includes 680 formulations. The Economic Times (India)/Press Trust of India (7/18)
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North America
Foundation awards $4.7M for prostate cancer test development
The Movember Foundation has awarded $4.7 million to a team of Canadian scientists to support the development of molecular diagnostic tests that could be used to guide the treatment of prostate cancer. Specifically, the team will design an assay that could pinpoint men who are at risk for aggressive prostate cancer and formulate customized treatments for early cancers. GenomeWeb Daily News (free registration) (7/17)
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CMS withdraws planned limits on hospice drugs in U.S.
The CMS pulled its proposed restrictions of private insurance coverage for hospice drugs under Medicare because they were blocking some terminally ill patients' access to drugs. Prior approval for coverage of anxiety drugs, laxatives, anti-nauseants and analgesics will now be required, instead of for all hospice drugs under Medicare Part D as announced in March. "Based on discussions with stakeholders, we are adjusting our rules so that beneficiaries enrolled in hospice will continue to have access to their medications," said CMS spokesman Raymond Thorn. Reuters (7/18), The Hill (7/18)
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Chief of FDA's Indian office steps down
Altaf Ahmed Lal, the U.S. FDA's head in India, has resigned along with other key officials of the agency's office in India. "Lal has since left FDA. We have nothing further to share," the agency's spokesman Christopher Kelly said. Carl Sciacchitano is serving as the agency's acting director after Lal's departure. Business Standard (India) (7/21)
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Shire accepts AbbVie's $55B takeover bid
U.K. drugmaker Shire has accepted AbbVie's takeover offer for about $55 billion in a deal that will allow the U.S. firm to reduce its reliance on arthritis treatment Humira and slash its corporate tax rate by relocating to the U.K. The firms plan to establish a new company that will be incorporated on Jersey and tax-domiciled in Britain. The acquisition is expected to be finalized in the fourth quarter. Reuters (7/19), PMLive.com (U.K.) (7/18), ABC News/The Associated Press (7/18)
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Report: Global surgical navigation tech market poised for growth
A report from Transparency Market Research predicts that the worldwide market for surgical navigation tools could increase from $218.5 million last year to $295.5 million by 2020. The market was dominated by North America last year, but the Asia-Pacific region is predicted to have the biggest potential for growth, the report notes. BeckersSpine.com (7/17)
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DIA News
Get the latest updates in diagnosing and managing adverse drug reactions
Book your place at two events to be held back to back at the same venue in Paris, France, and save up to €490! The Medical Approach in Diagnosis and Management of ADRs training course, from Sept. 22 to 23, will focus on how to use medical knowledge in the diagnosis and management of selected adverse drug reactions (ADRs) in clinical trials and post authorization. Then, the new Diagnosis and Management of Drug-Induced Liver Injury (DILI) training course, from Sept. 23 to 24, will highlight the progress made in the clinical detection and prevention of DILI in clinical trials and in the post-marketing phase. Find out more.
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Learn the essentials of statistics in clinical trials
The application of statistics is critical to the design and analysis of clinical trials, which are a long and costly process. Attend the 2014 DIA Statistics Workshop in Wuhan, China, from Sept. 25 to 26 to receive a broad introduction to the essentials of statistical principles and their application to clinical trials, including oncology clinical development. The workshop will feature real case examples. Download the program.
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I give myself sometimes admirable advice, but I am incapable of taking it."
-- Mary Wortley Montagu,
British writer
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