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.

Government 98

Government Pharma Training Ethics 98

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.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

Pharmaceutical Technology

SEPTEMBER 12, 2022

This dosage was chosen as the preferred dose in children aged under five years based on safety, tolerability and immunogenicity findings. In accordance with the recommendations of the Canadian government and public health authorities across the country, the companies plan to commence shipping the 3?g

Food and Drug Administration 52

Food and Drug Administration Government Food Safety 52

pharmaphorum

JANUARY 30, 2023

Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs. As such, new strategies have to be devised to encourage continued investment into the area.

Food and Drug Administration 104

Food and Drug Administration Medicine Manufacturing Pharmaceutical 104

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? Panelists were asked to discuss the potential use of the drug during pregnancy.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Salesforce

JUNE 28, 2024

These include: Data governance Data analytics Data collection Patient safety Regulatory compliance When done correctly, these tasks set standards for how data is collected, stored, used, and shared. This will require careful data governance to assure that data is HIPAA-compliant, secure, and in the right format for AI.

Management 59

Management Electronics Food and Drug Administration Recruitment 59

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

Medico Reach

OCTOBER 17, 2022

From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Pharmaceutical Technology

APRIL 25, 2023

Storage in other conditions can cause damage to the antigen or adjuvant and reduce the vaccine’s safety or efficacy. Long-term storage and delivery of vaccines are vital, especially as governments seek to vaccinate rural and remote communities. The majority of this rise came from the African region.

Food and Drug Administration 69

Food and Drug Administration Government Prospecting Food 69

Pharma Marketing Network

OCTOBER 3, 2024

A strong brand message conveys the unique value proposition of the pharmaceutical product, highlighting its benefits, efficacy, and safety. The pharmaceutical industry is highly regulated, with strict guidelines governing the promotion of products to ensure patient safety and ethical standards.

Marketing 52

Marketing Pharmaceutical Healthcare Healthcare 52

European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

Manufacturing 145

Manufacturing Food and Drug Administration Safety Engineering 145

World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

Food and Drug Administration 203

Food and Drug Administration Government Safety Manufacturing 203

Pharmaceutical Technology

JULY 7, 2022

In December last year, China’s National Medical Products Administration (NMPA) granted approval for amubarvimab/romlusevimab combination to treat mild and normal Covid-19 in adults and paediatric patients aged 12 to 17 years. The initial commercial batch of the antibody therapy was released on 7 July this year. 2 subvariants.

Food and Drug Administration 105

Food and Drug Administration Distribution Government Food 105

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs kill more than 250,000 children a year, doctors warn. About the author. The Guardian.

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

European Pharmaceutical Review

FEBRUARY 5, 2025

This guidance aims to streamline access pathways for patients, without compromising on the safety of these personalised immunotherapies. The recommendations cover product design and manufacture, evidence needed show safety and effectiveness, and post-approval safety monitoring, according to the MHRA.

Food and Drug Administration 52

Food and Drug Administration Government Safety Medicine 52

Pharmaceutical Representative Training

JUNE 22, 2024

They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Regulatory Compliance: Compliance with regulations must be fully understood by representatives.

Sales 52

Sales Pharmaceutical Ethics Pharmaceutical Sales 52

European Pharmaceutical Review

JUNE 8, 2023

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. He is currently a CMC consultant with an interest in impurities and safety‑based limits. References Smoking, Drinking and Drug Use among Young People in England, 2021. Internet] NHS Digital.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

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. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

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 US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Medicine Marketing 52

European Pharmaceutical Review

JANUARY 2, 2025

Here, collaboration between academic researchers, drug developers, and CDMOs will be key to making progress in identifying base modification strategies and leveraging them in therapeutic candidates. With this promise comes the responsibility of drug developers and RNA manufacturers to help RNA therapeutics reach their full potential.

Manufacturing 69

Manufacturing Food and Drug Administration FDA Pharmaceutical 69

Pharmaceutical Technology

JUNE 30, 2022

Pfizer and BioNTech have entered a new vaccine supply agreement worth $3.2bn with the US government to supply further doses of their Covid-19 vaccine. As per the agreement, the government will procure 105 million 3µg, 10 µg and 30 µg doses of the vaccine.

Government 98

Government Food and Drug Administration FDA Food 98

European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

Food and Drug Administration 97

Food and Drug Administration Safety FDA Ethics 97

European Pharmaceutical Review

AUGUST 10, 2022

the co-ordination of independent monitoring studies on the use, effectiveness and safety of medicinal products intended to be used against monkeypox. 8 With priorities including: providing scientific advice and reviewing available scientific data on medicinal products that have the potential to address the emergency.

Food and Drug Administration 96

Food and Drug Administration Medicine Government FDA 96

European Pharmaceutical Review

APRIL 2, 2025

3 High attrition rates in early clinical trials have bedevilled the industry in recent years, and the average likelihood of approval (LOA) for a new Phase I drug is now just 6.7 17 AI also has useful applications in GMP manufacturing of drug substance and drug products. How Successful Are AI-Discovered Drugs In Clinical Trials?

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Manufacturing FDA 52

World of DTC Marketing

SEPTEMBER 28, 2020

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Food and Drug Administration 163

Food and Drug Administration Pharma Side effects Food 163

Pharmaceutical Technology

SEPTEMBER 14, 2022

Opdivo is a programmed cell death receptor-1 (PD-1) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of several cancers. A phase II study of GX-188E, combined with Keytruda, also explored the safety and effectiveness of treatments in PD-L1+ and PD-L1-negative cervical cancer patients. .

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 59

European Pharmaceutical Review

APRIL 8, 2025

One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

World of DTC Marketing

MAY 6, 2021

The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad. This is the right and moral decision.

Pharma 185

Pharma Food and Drug Administration Government Insurance 185

European Pharmaceutical Review

FEBRUARY 14, 2025

Key drivers include a rise in demand for high-quality water in the pharmaceutical industry, automation and government initiatives. This includes the EUs Horizon Programme aimed at investing in research, and the US Food & Drug Administration (FDA) providing regulatory guidelines for producing and using water in drug manufacturing.

Pharmaceutical 52

Pharmaceutical Marketing Food and Drug Administration Government 52