European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. N Engl J Med.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S.,

Patients 52

Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Transportation Manufacturing 94

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. Ethical leadership is essential in promoting a culture of integrity within an organisation. What are three current key trends in data integrity?

Government 88

Government Pharma Ethics Training 88

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

Legacy MEDSearch

AUGUST 10, 2023

Acorai has ethics approval in 5 countries, including the U.S., “A massive inflection point in our device development journey” Acorai’s CEO and Co-Founder Filip Peters said, “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company. .

Food and Drug Administration 52

Food and Drug Administration Management Recruitment Medical 52

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.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

Nixon Gwilt Law

DECEMBER 16, 2021

So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., She also emphasizes that “opportunities for SaMD to enhance patient care will continue to evolve, and the time to begin thinking about an FDA pathway for your software is now.” Don’t wait!

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

World of DTC Marketing

MARCH 17, 2022

Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found. sustaining life)? In 2018 cancer patients in the U.S.

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255

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.

Media 52

Media Pharma Ethics Consulting 52

Cadensee

JULY 20, 2021

So, it's important for moral reasons, for ethical reasons, but it's really, really, really empowered by digital. It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make?

Food and Drug Administration 52

Food and Drug Administration Doctors Healthcare Healthcare 52

World of DTC Marketing

AUGUST 25, 2020

That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. I spent a lot of time in my career working with and talking to clinical scientists about the “drug approval process” The more questions I asked the more I learned. scientists. Dr. Stephen Hahn, the F.D.A.’s

Food and Drug Administration 188

Food and Drug Administration FDA Ethics Prescription 188