pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 70

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

PM360

AUGUST 9, 2022

Brand Beat: Juul Fights FDA Ban. Shortly after banning Juul from selling its products, the FDA placed a hold on its decision in order to review the company’s case more closely. however, the company is required to prove to the FDA that their e-cigarettes in fact benefit the public. FDA Update. Drug Approvals.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Food and Drug Administration Manufacturing Management Safety 83

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.

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Manufacturing Food and Drug Administration FDA Pharma 52

Pharmaceutical Technology

JULY 12, 2022

Novavax has signed an agreement with the US Department of Health and Human Services (HHS), in partnership with the Department of Defense, under which the US government will procure 3.2 Presently, the EUA application for the vaccine submitted by the company is being reviewed by the FDA.

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Food and Drug Administration FDA Government Physicians 64

European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

Medicine 101

Medicine Food and Drug Administration Ethics Government 101

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

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Government Pharma Ethics Training 90

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 79

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

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Medicine Food and Drug Administration Doctors Government 117

European Pharmaceutical Review

MARCH 2, 2023

However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022. Improvements were also seen in the drug development process itself.

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Food and Drug Administration Government Management Medicine 87

European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

Medicine 93

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 93

Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the drug and biotechnology sectors have continued to perform well in the second half of 2022. This can lead to significant losses for large companies.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Sales Medicine 52

Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Some restrict or prohibit certain disclosures of drug and alcohol treatment records for minors, for example. The 3 Key Legal Aspects of Developing Digital Health Tools for Children and Teens 1.

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Food and Drug Administration Education Insurance Healthcare 52

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S.

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Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

Manufacturing 87

Manufacturing Pharma Food and Drug Administration Safety 87

pharmaphorum

SEPTEMBER 28, 2022

” There’s a great deal of momentum in the healthcare community, including the pharmaceutical sector, to increase personalised care options using data. Food and Drug Administration (FDA). Minor variations in one’s genetic makeup can impact individual responses to medication.

Medicine 78

Medicine Food and Drug Administration Medical FDA 78

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Food and Drug Administration Safety FDA Ethics 10

MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx.

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Food and Drug Administration Prescription Government FDA 103

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Food and Drug Administration Medicine Manufacturing 77

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. While Zolgensma is also being investigated in the form of an injection, the MOA currently approved by the FDA is a single infusion.

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Food and Drug Administration Government Healthcare Healthcare 72

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. .” For example, in September 2022, the company Rebiotix, Inc.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 127

Medico Reach

OCTOBER 17, 2022

What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Healthcare executives are also looking into AR spinal surgical systems. Let’s dive right in!

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Pharmaceutical Technology

NOVEMBER 15, 2022

Paxlovid first hit the shelves in the US last December after the Food and Drug Administration (FDA) granted the treatment an emergency use authorisation (EUA). In late July, the US government placed an order for 105 million doses of Pfizer’s Covid-19 vaccine as part of a $3.2 Paxlovid rebound study.

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Food and Drug Administration Government Distribution FDA 64

pharmaphorum

JANUARY 30, 2023

This poses significant issues for healthcare systems in those countries, as those in the Northern Hemisphere are dealing with infectious diseases that commonly occur in winter. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 82

pharmaphorum

OCTOBER 3, 2022

Healthcare coverage is heterogeneous across emerging markets, with public funding limited by budgetary constraints. Indeed, in the US, the FDA has recently declined approval of Lilly’s sintilimab (Tyvyt), driven in part by a vote 14-1 against approval by the Oncologic Drugs Advisory Committee, owing to the availability of China-only data1.

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Food and Drug Administration Consulting Marketing Manufacturing 84

European Pharmaceutical Review

DECEMBER 15, 2022

Psilocybin therapy in mental healthcare. Mental healthcare should promote optimal quality of life through preventing, treating and managing mental health illnesses, such as depression, with the aim of facilitating sustained recovery. The introduction of psilocybin therapy could provide a potential step-change in mental healthcare.

Food and Drug Administration 69

Food and Drug Administration Healthcare Healthcare Food 69

Medico Reach

OCTOBER 17, 2022

What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. Healthcare executives are also looking into AR spinal surgical systems. Let’s dive right in!

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Pharma Food and Drug Administration Manufacturing Medicine 122

Pharma Marketing Network

JUNE 11, 2020

Yeah, I even wanted to wear the shirt to this FDA meeting. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. They would write up the presentations by physicians about drugs.

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Media Pharma Ethics Consulting 52

Legacy MEDSearch

JULY 20, 2023

Food and Drug Administration (“FDA”) for its XR90 augmented reality-based surgical visualization and navigation platform. “MediView is excited to receive 510(k) clearance for our XR90 platform and appreciate the team’s efforts and FDA’s partnership in achieving this milestone. .

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FDA Food and Drug Administration Recruitment Healthcare 52

Cadensee

JULY 20, 2021

02:25 Uri Goren talks about his road to become a trailblazer and advocate for patient-centric healthcare. 52:21 Uri's opinion about the main problem that needs to be solved for the healthcare market with technology. It might be silly question but bringing a drug to market takes many, many years. And it's shifting the power.

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Food and Drug Administration Doctors Healthcare Healthcare 52

World of DTC Marketing

OCTOBER 7, 2020

HEY NOW: The number of people who said that they would get a COVID vaccine is dropping rapidly because they don’t trust the FDA, drug companies, or the government to approve fully tested medications. Simple, they don’t trust the current administration to approve a vaccine without thorough testing.

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Healthcare Healthcare Food and Drug Administration Media 233

World of DTC Marketing

NOVEMBER 12, 2020

Pfizer did not take government money to develop a COVID vaccine and said the release of preliminary vaccine data was based on receiving the data on Monday. That, however, didn’t stop a conspiracy loving imbecile from blaming the FDA and Pfizer. years, including a median FDA review period (BLA submission to FDA approval) of 12.0

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Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. Already, [non-animal models] are assisting greatly in the repurposing of existing drugs,” he says. “We The FDA’s Modernization Act 2.0

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