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BioWorld - Sunday, March 22, 2026
Home » Topics » Medical technology, BioWorld

Medical technology, BioWorld
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U.S. Capitol building

Bills to ensure safety, supply of drugs and devices take first step toward passage

March 11, 2020
By Mari Serebrov
Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices.
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Stephen Hahn, FDA commissioner

FDA’s Hahn says need to deploy test for SARS-CoV-2 across platforms delayed development

March 11, 2020
By Mark McCarty
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
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Tablet, health professional, EHR/medical icons
Digital health developers, telehealth among the winners

CMS, ONC rules for electronic health records largely mirror both drafts

March 10, 2020
By Mark McCarty
The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.
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Postponed stamp on calendar

Preparing for COVID-19, FDA shuts down inspections, postpones meetings

March 10, 2020
By Mari Serebrov
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
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Coronavirus test tube, microscope, gloved hand

WHO releases COVID-19 roadmap; funding efforts in progress

March 9, 2020
By Nuala Moran
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
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U.S. flag and money

Senate passes COVID-19 spending bill 96-1, awaits POTUS sign-off

March 5, 2020
By Mark McCarty
The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
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U.S. Capitol building
Support for NIH boost still strong

DeLauro says House, Senate leaders agree on coronavirus supplemental

March 4, 2020
By Mark McCarty
The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.
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India’s restriction on API exports gives rise to more calls for U.S. drug, device manufacturing

March 3, 2020
By Mari Serebrov
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
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Empty prescription drug bottles

COVID-19 a fulcrum to push MEDS Act through Congress

March 2, 2020
By Mari Serebrov
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
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Europe under magnifier/petri dish with coronavirus

COVID-19: EU launches response team to coordinate efforts

March 2, 2020
By Nuala Moran
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
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