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Rx Drugs

June 03, 2021 | Daily News

The White House on Thursday (June 3) revealed that of the total 80 million COVID-19 vaccine doses the United States plan to share around the globe, an initial 25 million tranche will go to the World Health Organization’s COVAX initiative, which will send the doses to countries in South and Central America, South and Southeast Asia, and Africa.

June 03, 2021 | Daily News

FDA on Thursday (June 3) published four guidances that lay out how drug makers and trading partners can comply with certain requirements under the Drug Supply Chain Security Act, including how to identify and notify FDA of illegitimate drug products, and how to include product identifiers on product packages.

June 03, 2021 | Daily News

While health care costs for a family of four dropped 4.2% in 2020, spending on retail prescriptions drugs remained strong as mail order drug delivery surged and drug prices increased, according to the Milliman Medical Index.

June 03, 2021 | Daily News

Two House lawmakers reintroduced bipartisan legislation to create a state-based back-up to the existing federal stockpile of drugs at risk of shortages due to public health crises such as the pandemic.

June 03, 2021 | Daily News

FDA is not close to letting states import Canadian drugs, according to the Biden HHS’ response to PhRMA’s lawsuit against the Trump-era rule, and even if FDA were to allow imports, the Canadian government might not allow exports.

June 02, 2021 | Daily News

The National Institutes of Health is contemplating how to move forward with psychedelics research for mental health disorders like depression and post-traumatic stress disorder.

June 01, 2021 | Daily News

The National Institutes of Health on Tuesday (June 1) started a phase 1/2 clinical trial to test the safety and immunogenicity of giving a booster shot of Moderna’s COVID-19 vaccine to adults who have already been immunized with one of the three other COVID-19 vaccine regimens currently authorized by FDA.

June 01, 2021 | Daily News

The Supreme Court on Tuesday (June 1) denied Johnson & Johnson’s request that it review a Missouri court’s decision to award billions of dollars to 22 women who claimed J&J’s talcum powder products caused ovarian cancer.

May 28, 2021 | Daily News

In its fiscal 2022 budget justification released Friday (May 28), FDA identifies several legislative proposals it says could help with the agency’s COVID-19 pandemic response, including by giving FDA authority to require specific medical device supply chain information, request facility records in advance or in lieu of inspections, and share medical product information with state and local governments.

May 27, 2021 | Daily News

More than 155 House Democrats are pressuring the president to add Medicare benefits, paid for with government drug price negotiation, to his American Families Plan as Democrats try to regain a grip on drug pricing on the eve of President Joe Biden proposing his budget.

May 26, 2021 | Daily News

FDA on Wednesday (May 26) granted emergency use authorization to GlaxoSmithKline’s investigational monoclonal antibody, sotrovimab, for treatment of patients with mild-to-moderate COVID-19.

May 26, 2021 | Daily News

CMS on Wednesday (May 26) proposed a six-month delay of a measure that lets drug companies report multiple best prices for each drug when those prices are tied to so-called value-based payment arrangements.

May 26, 2021 | Daily News

HHS and FDA officials announced Wednesday (May 26) that they are reversing a Trump-era directive to eliminate FDA’s Unapproved Drugs Initiative through which the agency has tried to remove from the market any unapproved drugs. The officials say the Trump administration’s November attempt to withdraw the unapproved drugs program was “legally and factually inaccurate.”

May 26, 2021 | Daily News

FDA on Tuesday (May 25) revealed that it may decline to review and process anymore emergency use authorization requests for COVID-19 vaccines, especially if the agency is unable to verify product and manufacturing quality information or when a vaccine falls lower on the agency’s EUA priority list.

May 25, 2021 | Daily News

Moderna announced Tuesday (May 25) that it will soon ask FDA to clear the company’s COVID-19 vaccine for use in teens ages 12 to 17, coming as clinical trial data show the vaccine was 100% effective in teens.

May 25, 2021 | Daily News

FDA on Monday (May 24) finalized guidance that details how sponsors of molecularly targeted adult cancer drugs can demonstrate to FDA how those drugs can also be used in pediatric populations.

May 24, 2021 | Daily News

Former FDA chief Scott Gottlieb and former HHS Assistant Secretary for Health Brett Giroir sparred over the safety of kratom and who’s to blame for the lack of strict scheduling, coming just minutes after FDA announced the seizure of $1.3 million worth of kratom-containing dietary supplements and bulk dietary ingredients.

May 24, 2021 | Daily News

Food and drug law experts are closely watching a number of court cases in 2021, including one at the Supreme Court that involves consolidation of product liability lawsuits and could have implications for how courts handle case backlogs after COVID-19.

May 21, 2021 | Daily News

An amendment introduced in the Senate would curtail the Office of the U.S. Trade Representative’s authority to move ahead with World Trade Organization talks on a proposed waiver of certain intellectual property obligations through added “deliberation, transparency, and reinforced congressional oversight” provisions, according to Senate Finance Committee ranking member Mike Crapo (R-ID).

May 21, 2021 | Daily News

Days after HHS threatened to slap fines on drug makers, Eli Lilly on Thursday (May 20) asked a federal judge to stop HHS from penalizing companies, starting June 1, that restrict discounts to hospitals that dispense 340B drugs through multiple contract pharmacies.

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