Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Development 52

Development 52

Pharma in Brief

JANUARY 7, 2024

This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

JAMA Internal Medicine

FEBRUARY 12, 2023

This cross-sectional study evaluates regulatory decisions and health technology assessments in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration in 2017 through 2020, as well as estimates the US cost per patient per year for drugs receiving negative recommendations.

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FDA Approval Drugs 76

JAMA Internal Medicine

JUNE 21, 2021

This cross-sectional study uses administrative health care data on 2.9 million households from the first 45 weeks of 2020 to assess the association between social gatherings and SARS-CoV-2 transmission by studying whether COVID-19 rates increase after birthdays in a household.

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Rethinking Clinical Trials

DECEMBER 12, 2023

ACP PEACE Reaching ambulatory older adults with educational tools: comparative efficacy and cost of varied outreach modalities in primary care Structural barriers to well-grounded advance care planning for the seriously ill: a qualitative study of clinicians' and administrators' experiences during a pragmatic trial Forms or free-text?

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Trials Clinical Trials Clinical Trials Nurses 141

Cloudbyz

JULY 19, 2023

This section outlines the importance of pharmacovigilance in identifying and minimizing risks, ensuring participant safety, and maintaining the integrity of clinical trial data. This section explains the process of adverse event collection, classification, and reporting.

Clinical Trials 85

Clinical Trials Clinical Trials Trials Compliance 85

Scienmag

MAY 24, 2022

PITTSBURGH, May 24, 2022 – A grim prediction made half a decade ago by University of Pittsburgh School of Public Health epidemiologists and modelers has come true: More than 100,000 people are now dying from drug overdoses annually in the U.S.

Drugs 79

Drugs 79

Rethinking Clinical Trials

JULY 6, 2023

Remote Tai Chi (or Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial) is supported by the National Center for Complementary and Integrative Health (NCCIH). Michele Balas and Eduard Vasileviskis will serve as BEST-ICU's co–principal investigators.

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Trials Nurses Medicine Clinical Trials 246

Scienmag

NOVEMBER 11, 2021

INDIANAPOLIS – An all Indiana University School of Medicine team of researchers led by, Rajiv Agarwal, MD, professor of medicine and staff physician at the Roudebush VA, and including Arjun Sinha, MD, associate professor of clinical medicine and renal section chief at the Roudebush VA, and Wanzhu Tu, PhD, professor of biostatistics and health data (..)

Medicine 86

Medicine Research 86

Pharmacy Checkers

DECEMBER 18, 2020

In late September, Secretary Azar, in a final rule , certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J).

Pharmacy 85

Pharmacy Drugs Cosmetics Licensing 85

Pharma in Brief

DECEMBER 3, 2023

For example, in 1993, the Federal Court of Appeal ( FCA ) held that section 6 proceedings would run as applications, meaning that discovery was generally unavailable and cases would be heard on only a written record, without a trial. [3] Revised section 8 damages. Evolution of the Regulations Coming into force (1993–1997). Fast-paced.

Regulation 52

Regulation Compliance Medicine Manufacturing 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 16, 2024

The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. The post Report Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies appeared first on CTTI.

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Clinical Trials Clinical Trials Trials Production 58

Drug Channels

APRIL 2, 2024

For more on acquisition cost reimbursement for pharmacies, see Sections 8.4. CVS Health thinks so, as evidenced by two new initiatives that it announced yesterday. CVS Health thinks so, as evidenced by two new initiatives that it announced yesterday. and 12.3.4. of our new 2024 Economic Report on U.S.

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Pharmacy Drugs 65

Pharma in Brief

FEBRUARY 13, 2024

The application of the ordinary test for trademark confusion was not affected by the fact that the names of both products had been approved by Health Canada. The FC found the Respondents liable for infringement on the basis that BYOOVIZ was confusingly similar to theBEOVU registered mark (section 20), as well as passing off (subsection 7(b)).

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Branding Drugs Manufacturing Production 59

JAMA Internal Medicine

JULY 25, 2021

This cross-sectional study examines the association of Medicare with racial and ethnic disparities in access to care and health.

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Pharmaceutical Technology

JUNE 5, 2023

Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Cybersecurity is necessary for biosecurity.”

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Compliance Regulation Pharmacy Genome 276

JAMA Internal Medicine

MARCH 29, 2021

This cross-sectional survey study investigates COVID-19 vaccine intentions among racially and ethnically diverse samples of health workers and the general population.

Vaccination 63

Vaccination Vaccine 63

Medical Xpress

MARCH 28, 2023

Researchers have conducted a cross-sectional study of patient satisfaction among adult participants with chronic low back pain in a national pain research registry using self-reported measures of physician communication, physician empathy, current physician opioid prescribing for low back pain, and outcomes pertaining to pain intensity, physical function, (..)

Doctors 52

Doctors Doctor Medicine Research 52

JAMA Internal Medicine

AUGUST 10, 2020

This cross-sectional study assesses the rate of COVID-19 infection among health care workers in a large community hospital.

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Scienmag

JUNE 14, 2021

(Boston)–Despite evidence regarding the benefits of vaginal birth after cesarean and recommendations to support shared decision making to reduce cesarean rates, minority women face many impediments that limit their access to appropriate health information and opportunities for such discussions.

Medicine 75

Medicine 75

JAMA Internal Medicine

AUGUST 2, 2020

This cross-sectional study uses 2018 data from the National Health and Aging Trends Study to assess the prevalence among older adults in the United States of unreadiness to access video or telephone telemedicine because of disability or inexperience with technology.

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JAMA Internal Medicine

JULY 12, 2020

This cross-sectional study compares health care outcomes in middle-aged adults in the US vs England by income status.

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FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. The most significant proposed update is the addition of a new section to the 2018 guidance on reducing disparities in health and health care.

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Production Marketing 59

Drug Channels

OCTOBER 10, 2023

No other report on the market today offers the depth, insight and analysis into these channels This 2023-24 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson. and Section 6.4.3.

Pharmacy 40

Pharmacy Licensing Licensing Containment 40

XTalks

DECEMBER 13, 2023

Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head. Dr. Buchwald applies her experience in public health and basic science research to expand Merck’s pneumococcal vaccine franchise and the development of next generation adult and pediatric pneumococcal conjugate vaccines.

Life Science 52

Life Science Vaccination Vaccine Scientist 52

Pharmacy Checkers

JANUARY 27, 2021

This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule.

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Drugs Pharmacy 125

FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Section II at 2. See 21 U.S.C. 353b(a)(8). the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(e)

Drugs 52

Drugs Production Manufacturing Licensing 52

FDA Law Blog

APRIL 24, 2024

The final rule was identified by OMB as Section 3(f)(1) significant meaning that the rule “may have an annual effect on the economy of $200 million or more. ; Bottom line – OMB did not object and FDA just cleared one more hurdle on its way to issuing the final rule.

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Regulation In-Vitro Production 59

FDA Law Blog

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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Regulation Drugs FDA Approval Production 59

FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses.

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Compliance Manufacturing Containment Regulation 105

Pharmacy Checkers

MARCH 5, 2021

I reviewed the drug relabeling section of Florida’s Drug Importation Program submission to the U.S. Department of Health and Human Services, and it really tells a story. It’s called parallel trade; it results in price competition – and that’s what states are doing with Section 804. That’s the name of the game here!

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Drugs Production Manufacturing Marketing 89

Drug Discovery World

SEPTEMBER 28, 2023

This article will focus on one such area of great unmet need and promise: women’s health. Women’s health microbiome-based drug development landscape Despite their limited historical interest, pharma/biotech companies are now increasingly interested in the female microbiome and its role in drug development.

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Clinical Trials Clinical Trials Regulation Bacteria 64

Pharmaceutical Technology

NOVEMBER 17, 2022

The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update.

Hormones 257

Hormones Compliance Research 257

FDA Law Blog

JANUARY 22, 2023

FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The memorandum summarizes each section of FDORA and analyzes the new law’s potential effects on the FDA-regulated industry. 117-328 (2022). has prepared a detailed Summary and Analysis of FDORA.

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Cosmetics Regulation Drugs Production 59

FDA Law Blog

JANUARY 7, 2024

Potential enforcement actions can include an FDA Warning Letter, charges under section 505(o)(1) of the FDCA, misbranding charges under section 502(z), or civil monetary penalties. However, the language in the Draft Guidance omits the requirement in Section 505(o) that “ available data ” must indicate the potential for a serious risk.

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Marketing Drugs Regulation Cosmetics 59

Drug Channels

OCTOBER 17, 2023

In case you haven’t noticed, private equity firms have displaced hospitals and health systems as the major acquirers of community oncology practices. FYI: Today’s article is adapted from Section 6.3. The Federal Trade Commission’s (FTC) has a newfound interest in the roll-up transactions that are creating practice management companies.

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Drugs 74

pharmaphorum

JANUARY 5, 2023

But for the pharma sector, it means meetings all over town in San Francisco and presentations by anybody who’s anybody in pharma, life sciences, and, increasingly, digital health. And then come back to our video section for more throughout the winter. For most people, the name “JP Morgan” means bankers and investors.

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Life Science 90