Fierce Pharma

AUGUST 16, 2023

Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines. Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found.

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Drug Store News

NOVEMBER 30, 2023

The report summarizes the proceedings of CRN's annual Scientific Symposium, which brought together experts to shed light on the critical issues surrounding global nutrition challenges and policy efforts.

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PhRMA

MARCH 1, 2023

Food and Drug Administration (FDA) are in the process of considering new collaboration initiatives aimed at biopharmaceutical patents.

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FDA 207

STAT

APRIL 1, 2024

LONDON — Neurologists and patient advocates are up in arms over a policy decision by a U.K. And the issue is how the U.K.’s health agency that they say will imperil access to an ALS treatment that’s available in the U.S. and on its way to approval in the European Union.

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Pharmacy Times

APRIL 19, 2023

The findings could inform revisions to safety guidelines and policies that help protect people with cardiovascular issues during heat waves.

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Fierce Healthcare

JULY 17, 2023

Friday, the Federal Trade Commission (FTC) announced its withdrawal of two policy statements outlining its former position on antitrust enforcement in healthcare markets, echoing a similar decision | The two policy statements, issued in 1996 and 2011, "no longer reflect market realities in this important sector of the economy," the regulator (..)

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STAT

SEPTEMBER 6, 2022

In a long-overdue move, the federal Office of Science and Technology Policy has issued guidance on making federally supported research and publications available to all without delay or embargo. These issues must be considered as this policy takes shape. Read the rest…

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Drug Topics

FEBRUARY 2, 2023

Experts say Democrats and Republicans could work together on a variety of policy issues over the course of the year.

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STAT

APRIL 4, 2024

government agency tasked with ensuring the safe use of radioactive materials issued a recent report that the agency’s advisers had key undisclosed conflicts of interest, raising fresh concerns about controversial decisions around the reporting of radioactive injection accidents. The oversight division of a U.S.

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Pharmacy Times

SEPTEMBER 21, 2022

There are several important policy issues that could impact pharmacists’ ability to positively affect the quality of care for patients through the use of pharmacy performance measures.

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STAT

OCTOBER 4, 2023

The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. Other committees that have tried tackling the issue have jurisdiction mostly over the Food and Drug Administration. The panel is tentatively aiming to hold a hearing on the issue in November, the sources said.

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Hospital Pharmacy Europe

APRIL 4, 2024

The importance of pharmacy professionals signposting children and young people experiencing gender identity issues such as gender incongruence or dysphoria to appropriate support services has been emphasised by the General Pharmaceutical Council (GPhC).

Hospitals 52

Hospitals 52

STAT

NOVEMBER 9, 2023

Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. And then there were five (well, six) A pared-back field of five GOP presidential candidates sparred Wednesday night, touching on health issues ranging from hot-button election topics, to wonky budget math.

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Hospitals 98

STAT

JANUARY 25, 2024

Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  They would be the first subpoenas issued by the Senate HELP committee in more than 40 years, if the vote happens and goes in Chair Bernie Sanders’ favor.

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STAT

MARCH 7, 2024

Forty years of affirmative action policies were unable to compensate for the devastating impact of the 1910 Flexner Report, which led to the mass closure of medical schools that admitted Black students, and an estimated loss of 35,000 Black physicians into the field. But the truth is more complicated than that. Read the rest…

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Medical Schools 145

STAT

APRIL 18, 2024

The about-face illustrates the difficulty the biotech industry faces in dealing with an issue that, fueled by national security concerns, is moving fast and forcefully. It also tests the ability of Crowley, who lacks a background in politics, to navigate a domestic policy issue that is tangled up in U.S.-China China relations.

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STAT

DECEMBER 11, 2023

The medical device lobby also announced the creation of a new division focused on policy issues for medical imaging technology. AdvaMed named Peter Arduini, CEO of GE HealthCare, chair of its board of directors on Monday. The announcement formalizes his position, which he will serve in for two years.

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The FDA Law Blog

OCTOBER 5, 2023

Walsh — DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition. This new policy only applies to the disclosure of criminal conduct, not administrative or regulatory violations.

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FDA 59

European Pharmaceutical Review

MARCH 12, 2024

Life science companies are investing in comprehensive data governance strategies to establish clear policies, procedures and controls for managing data. This involves regularly conducting internal audits and inspections to identify any potential gaps or non-compliance issues that need to be addressed. Training and education.

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The FDA Law Blog

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. (“HP&M”) is pleased to announce that Ana Loloei has joined the firm as Counsel.

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STAT

JUNE 22, 2023

Doctors’ lobbyists in Washington tend to focus their energies on ensuring Medicare pays well, and on issues like so-called scope of practice laws. Whether from their lobbying or others, that first policy only forced researchers to make their work free after 12 months.

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PhRMA

MAY 8, 2023

These policies work together to foster pediatric drug development, enabling biopharmaceutical companies to continue making significant investments in critical research areas for children. Food and Drug Administration (FDA) issued a BPCA written request to the sponsor for studies in pediatric cGVHD patients. In

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FDA 210

STAT

AUGUST 1, 2023

Three large and growing physician groups backed by the private equity giant Welsh, Carson, Anderson & Stowe have hired a prominent lobbying firm to influence federal policy covering mergers and acquisitions. Over the past two weeks, United Musculoskeletal Partners, U.S. Anesthesia Partners, and U.S. Forbes Tate also did not respond.

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Hospitals 98

STAT

JULY 12, 2023

LONDON — The European Union on Wednesday issued an antitrust fine of $475 million to the U.S. The commission called Illumina’s actions “an unprecedented and very serious infringement” of the EU’s policies, including the “cornerstone” that regulators review deals that can alter the market.

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The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. FDA concluded that the CPG limited its ability to act against unsafe homeopathic drug products and decided to develop a risk-based enforcement policy.

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The FDA Law Blog

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Again this year, the Annual Report that was released last week did not feature much in the way of specific quality issues. By John W.M.

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STAT

NOVEMBER 7, 2023

The move comes two months after the FTC issued a policy statement noting some drug companies have failed to follow requirements for listing patents in the Food and Drug Administration’s Orange Book in hopes of thwarting competition from lower-cost generic medicines.

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Generic Medicine 114

STAT

FEBRUARY 17, 2023

In December, he was named chairman of a new 12-person congressional commission tasked with issuing a set of policy recommendations for how the U.S. This year, Kelly will have a chance to advocate more formally. government can keep the country’s biotech industry competitive and capable of serving national security needs.

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STAT

SEPTEMBER 1, 2022

An expert committee that advises the Centers for Disease Control and Prevention on vaccine policy voted on Thursday to recommend use of updated Covid-19 vaccines. With the positive votes from the Advisory Committee on Immunization Practices, the issue now goes to CDC Director Rochelle Walensky.

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Hospital Pharmacy Europe

SEPTEMBER 26, 2023

Environmental sustainability within pharmacy is the subject of a new policy statement published by the International Pharmaceutical Federation (FIP) as it calls for action on climate change. C or 2°C above pre-industrial levels.

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Hospitals 105

STAT

AUGUST 30, 2023

At issue is the cost of bedaquiline, which is the backbone of different combination therapies used to treat multi-drug-resistant tuberculosis. But advocacy groups continue to argue that Johnson & Johnson, which makes the pill, has stymied wider access.

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STAT

JULY 27, 2023

To narrow the nation’s deeply entrenched health disparities, a permanent entity with regulatory powers should be created by the president to oversee health equity efforts across the entire federal government, says a report issued Thursday by the National Academies of Science, Engineering, and Medicine.

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STAT

MARCH 14, 2023

At issue is the NRC’s policy that exempts practitioners of nuclear medicine — clinicians who use radioactive pharmaceuticals to diagnose or treat disease — from having to report when they mistakenly inject radiopharmaceuticals into a patient’s tissue rather than into a vein as intended.

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STAT

JANUARY 6, 2023

In Nebraska, the state’s inspector general of corrections requested that the prison explain a policy, obtained by STAT, requiring that incarcerated people sign a consent form that misrepresents the benefits of available hepatitis C treatments. Lawmakers in other states are pledging broader probes into the issue, too.

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STAT

APRIL 12, 2023

The White House on Wednesday issued an unprecedented warning about xylazine , the veterinary tranquilizer increasingly found in the illicit opioid supply. Beginning today, the substance will be classified as an “emerging drug threat” — the first designation of its kind.

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STAT

SEPTEMBER 20, 2023

The policy would phase out patents and regulatory exclusivities and, in place of intellectual property protections, the U.S. A measure was passed directing the National Academies of Sciences, Engineering, and Medicine to study the idea and was added to the Pandemic and All-Hazards Preparedness Act. So, why prizes and not patents?

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STAT

AUGUST 11, 2023

WASHINGTON — A White House task force created to work on drug shortage reforms has yet to contact the lawmakers who are writing legislation to stem shortages — and it’s not clear when the task force will recommend policies.

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