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Daily News

July 10, 2020

FDA announced Friday (July 10) it will begin conducting announced domestic facility inspections for the first time since March.

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July 09, 2020

The Trump administration must designate a point person whose sole job is to lead the federal government’s coronavirus testing efforts, which Democrats allege were flawed from the start and continue to face challenges due to lack of leadership, according to a 30-page report by Democratic staff of the Senate health committee.

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Big brand-drug executives announced Thursday (July 9) that they’ve created a $1 billion fund to help small- to mid-sized companies develop breakthrough antibiotics because, they said, the market is broken and resistance to existing antibiotics is growing.

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FDA biologics center director Peter Marks said the agency hasn’t ruled out letting sponsors conduct human challenge trials for COVID-19 vaccines.

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HHS on Thursday (July 9) announced that it has awarded more than $21 million to community health centers, including facilities in the Health Center Program look-alikes, with funding to support COVID-19 testing.

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House Appropriators on Thursday (July 9) passed out of committee an FDA funding bill that would give the agency authority to mandate the recall of unsafe prescription and over-the-counter drugs.

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HHS will do everything it can to permanently keep telehealth waivers granted during the pandemic, HHS Secretary Alex Azar said Thursday (July 9) at The Hill virtual event on the future of health care.

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The Federal Communications Commission on Wednesday (July 8) awarded another $10.73 million to 25 health care providers in rural and urban areas of the country as part of its COVID-19 response fund for telehealth services.

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Regulatory experts say drug and medical device makers want more clarification about FDA’s view on decentralized clinical trials and how new flexible trial policies, including options for remote visits and monitoring, will be applied beyond the COVID-19 pandemic.

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The National Institute of Allergy and Infectious Diseases has merged four NIAID-funded clinical trial networks to create a new trial network that will recruit thousands of patients into large-scale clinical trials for investigational COVID-19 vaccines and monoclonal antibody therapies.

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July 08, 2020

The Supreme Court Wednesday (7-2) upheld the Trump administration’s rule that lets employers refuse to provide cost-free contraceptives to workers due to religious or moral objections, saying the Affordable Care Act grants HHS the discretion to set that policy.

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A group of nine Senate Democrats, led by Senate health committee ranking Democrat Patty Murray (WA), asked HHS Secretary Alex Azar to scrap the Trump administration’s rule that rolls back the Affordable Care Act’s gender discrimination protections.

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Stakeholders are closely watching to see whether FDA will cave to pressure from the White House and doctors and reinstate emergency use authorization for the anti-malarial drug hydroxychloroquine.

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The task force set up by the presumptive Democratic presidential nominee Joe Biden (DE) and formal rival Bernie Sanders Wednesday (July 8) unveiled a unity platform on securing universal health care.

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Joe Biden would direct Medicare to negotiate prices of drugs that face little competition, using international prices as a reference, and the negotiated prices would be available to public and private insurers, according to the presumptive Democratic presidential nominee’s platform.

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As White House officials tease a buy-American executive order, Joe Biden this week issued his plan for bringing pharmaceutical manufacturing back to the United States, and some of the general principles of the two plans overlap.

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Republican lawmakers on the House Ways & Means Committee will soon introduce four bills aimed at providing additional incentives and tax benefits for pre-revenue companies, start-up businesses and partnerships that are focused on infectious disease drug development, committee staff members told reporters on a press call Wednesday (July 8).

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HHS will publicly release each state and local COVID-19 testing strategy on Friday (July 10) nearly two weeks after House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) demanded the plans from HHS because of the way the administration has delegated the task to states and localities.

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Nationwide patient identification advocates are gathering support from providers and health care technology leaders as they find new traction for reforms during the COVID-19 outbreak, which they say has reawakened the country to patient data matching problems.

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The American Civil Liberties Union says the Supreme Court’s recent 5­-4 decision to strike down Louisiana abortion restrictions boosts abortion care providers’ calls for FDA to remove prescribing and dispensing restrictions on the abortion pill mifepristone and shuts down the agency’s arguments that clinicians have no standing to assert patients’ rights to access the drug.

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