Policy – Page 2 – media

FDA Announces 3 New Digital Health Policy Changes

FDA Commissioner Scott Gottlieb, MD, today announced 3 policy changes meant to encourage digital health innovation while modernizing the agency’s oversight of new tech.
- Source: hcanews
- 1,325
- December 8, 2017
digital health FDA innovation Policy
Winter could ‘break the backbone’ of the NHS

Health service experts are warning that the NHS could be “sorely tested” in the coming months as it is already running at near maximum capacity with “severe pressure” on the horizon.
- Source: pharmatimes
- 519
- December 8, 2017
NHS Policy
Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.
- Source: raps.org
- 702
- December 4, 2017
cancer FDA NIH Policy
FDA Announces New Policy for Genetic Testing Regulation

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
- Source: jdsupra
- 536
- November 10, 2017
direct-to-consumer genetic risk Policy
FDA Widens Scope of Navigator – Information Tool for Expanded Access

FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency needs to take new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval.
- Source: blogs.fda.gov
- 582
- November 6, 2017
FDA orphan Policy treatment
China to adjust registration management for drugs and medical devices

To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.
- Source: china-briefing
- 1,200
- October 23, 2017
CFDA drug medical device Policy
Australia’s second largest state edges towards permitting euthanasia

The parliament of Australia’s second largest state passed legislation on Friday to allow terminally ill patients to seek medical help to end their lives, a bill that is expected to act as a catalyst for the rest of the country to adopt similar laws.
- Source: reuters
- 567
- October 20, 2017
catalyst euthanasia Market Views Policy
Court ruling not needed to withdraw care, judge says

Legal permission will no longer be required to end care for patients in a permanent vegetative state, a judge has ruled.
- Source: BBC
- 421
- September 25, 2017
patient permission Policy
ABPI seeks to challenge NICE reforms in court

The Association of the British Pharmaceutical Industry is seeking to challenge in court new rules on appraising medicines for NHS use, insisting that the changes will hinder patient access to the latest medical innovations.
- Source: pharmatimes
- 822
- July 20, 2017
innovation Policy
launch of a new online database

WHO and the Population Division of the United Nations Department of Economic and Social Affairs have launched a new, open-access database of laws, policies and health standards on abortion in countries worldwide. The database aims to promote greater transparency of abortion laws and policies, as well as to improve countries’ accountability for the protection of women and girls’ health and human rights.
- Source: WHO
- 414
- July 15, 2017
abortion Policy

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