How Many Physicians Have Opted Out of the Medicare Program?

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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h

CDSA supports launch of ICMR TB vaccine trial - BSI bureau

This is the first-ever government led vaccine trial after the BCG vaccine trial that was undertaken decades ago. After a detailed land scape analysis of the available vaccine candidates, two potential vaccines were shortlisted for a ICMR led Phase III trial of 12000 healthy house hold contacts of sputum smear positive TB patients.

Clinical Development Services Agency (CDSA), launched by Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India in 2009, has provided study start-up support to all sites and oversaw the recruitment and vaccination of the first participant at National Institute of Tuberculosis and Respiratory Diseases (NITRD) New Delhi on 15th July 2019.

The trial launch at NITRD, Delhi was attended by Dr. Balram Bhargava, Secretary, DHR & Director General, ICMR, Dr. Rohit Sarin – Director, NITRD, Dr. Manjula Singh- Scientist “E” EDC, ITRC-ICMR project team and CDSA team members - Dr. Monika Bahl, Ms. Shubhra Bansal,  Mr. Tarun Puri and Ms. Jinisha Shukla.

Dr. Bhargava emphasised the need in India where the disease is endemic for clinical trials to show that the vaccine is safe and effective. Participants will be recruited from twelve sites in six states—Delhi, Karnataka, Maharashtra, Orissa, Tamil Nadu and Telangana.

CDSA is an extramural unit of Translational Health Science & Technology Institute (THSTI), Faridabad.



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