European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance.

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Drug Development Pharmaceutical Companies Pharmaceutical Companies Documentation 122

European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines.

Drug Development 98

Drug Development Documentation 98

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.

Compounding 97

Compounding Drug Development Documentation Pharmaceutical Companies 97

FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

Documentation 52

Documentation Labelling Drug Development 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.

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Drug Development Communication Dosage Chemotherapy 98

Drug Patent Watch

MARCH 25, 2020

This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0 link] Drug developers require access to scientific information in…. Unported License.

Documentation 69

Documentation Drug Development 69

pharmaphorum

APRIL 8, 2021

Drug development alone is not really working to solve [chronic illness],” he added, noting that BIOS aims to use AI to read these neural signals, find out how they work and eventually control them to produce a therapeutic effect. Remember, in 2020 much more people died from cancer than COVID-19. “I

Drug Development 93

Drug Development Vaccines Documentation Communication 93

pharmaphorum

FEBRUARY 10, 2021

As these solutions are further developed, the consortium will produce data collections for validation, regulatory pathways and technical standards. The post EU-funded project encourages use of simulation in drug development appeared first on.

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Drug Development Packaging Documentation Hospitals 76

PharmaTech

JULY 23, 2024

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.

Drug Development 52

Drug Development Documentation 52

Syner-G

SEPTEMBER 15, 2023

Process reliability and product consistency are critical during scaling up to commercial production, necessitating comprehensive documentation of process parameters, analytic results, and manufacturing data. This documentation supports process control, and optimization, and serves as a regulatory record of reliability and repeatability.

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Drug Development Documentation Process Improvement Compounding 59

Pharmaceutical Technology

JUNE 15, 2023

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

pharmaphorum

JANUARY 6, 2023

Simplicity and technology intersect to streamline drug development. Jim Reilly, vice president, development cloud strategy, believes that “the intersection of operational simplification and technology advancement will create cross-functional efficiency across clinical, regulatory, quality, and safety.

Documentation 111

Documentation Drug Development Diabetes 111

pharmaphorum

AUGUST 19, 2022

Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. The post Fuelling the efficiency of drug development through sensor data integration appeared first on.

Drug Development 52

Drug Development Documentation Hospitals 52

Pharma Leaders

MAY 12, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Drug Development 52

Drug Development Documentation 52

PharmaTech

DECEMBER 15, 2023

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Clinical Pharmacology 52

Clinical Pharmacology Documentation Drug Development 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

pharmaphorum

OCTOBER 28, 2022

In the early stages of drug development, it is logical to focus on the economic and clinical aspects of candidate identification: Is there enough of a market? The true value of a human-centered approach is much earlier in the development lifecycle. Could this candidate demonstrate clinical efficacy?

Drug Development 105

Drug Development Documentation 105

European Pharmaceutical Review

JULY 24, 2023

QMS market to value nearly $4b by 2030 A strategy for improving drug product quality Uriel et al. The data obtained is included in two documents and sent to all participants in the test: An individual report with details of the results specific to each participant. These are documented and their root cause is sought.

Compounding 93

Compounding Documentation Drug Development 93

pharmaphorum

AUGUST 24, 2022

Speakers at a recent Patients as Partners webinar on the document welcomed its publication, and explained how community and collaboration were the keys to turning theory into practice. How do you create better efficacy in the drugs that are being prescribed to work in a black body, at the cellular level?” Why, not how.

Documentation 111

Documentation Drug Development 111

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

pharmaphorum

MARCH 24, 2021

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. .

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Drug Development Documentation 69

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Building relevance. The patient centricity movement has been building momentum in recent years.

Drug Development 98

Drug Development Documentation 98

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Documentation 105

Documentation Drug Development Communication 105

pharmaphorum

AUGUST 31, 2021

However, like many other emerging healthcare technologies, they have been slow to gain traction and there is still confusion and scepticism around ECAs, stemming from a lack of precedence, step-by-step guidance and data to quantify their impact on drug development costs and clinical outcomes.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

Express Pharma

AUGUST 10, 2024

FDA had also planned a conference on innovation in Medical Product Development Regulatory Education for Industry (REdI) which included: 1) Drug track to address major advances and innovation across various aspects of the drug development spectrum, 2) Devices track to provide an overview of marketing approval and best practices for quality, safety (..)

Drug Development 105

Drug Development Vaccines Dosage Documentation 105

Syner-G

NOVEMBER 1, 2023

Just staying on top of the changes can present an ongoing challenge to drug developers, especially in the areas of new small molecules, biologics, cell and gene therapies, and medical devices. Other capabilities to look for include extensive experience with exploratory and creation stages of drug development.

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Drug Development Documentation 59

Syner-G

SEPTEMBER 28, 2023

Lastly, inadequate regulatory documentation can be avoided by meticulously compiling comprehensive, guideline-compliant, regulatory documentation. Pre-IND Meetings Pre-IND meetings offer substantial value in drug development, especially when sponsors have unanswered questions beyond FDA guidelines.

Documentation 59

Documentation Drug Development Packaging 59

Syner-G

OCTOBER 27, 2023

Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise within their teams. Poor documentation.

Documentation 52

Documentation Drug Development 52

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

pharmaphorum

NOVEMBER 10, 2021

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony.

Vaccines 105

Vaccines Documentation Drug Development 105

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

Documentation 108

Documentation Vaccines Drug Development 108

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment.

Documentation 119

Documentation Vaccines Drug Development 119

Pharmaceutical Business Review

MAY 31, 2024

The company also launched AutoIND, an AI-powered platform designed to optimise the drafting, reviewing, and submitting of regulatory documents in drug development. It automates and expedites the planning, writing, and review process for Investigational New Drug (IND) applications.

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Drug Development Documentation 45

Syner-G

SEPTEMBER 20, 2023

By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization.

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Drug Development Documentation Dosage Packaging 59

Syner-G

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Category: Regulatory Affairs , Drug Development Consulting.

Documentation 52

Documentation Drug Development Communication 52

pharmaphorum

APRIL 21, 2022

Iris Loew-Friedrich, the organisation’s chief medical officer and head of development, tells pharmaphorum how the initiative will help guide the creation of a mutually beneficial, truly inclusive pharma. Moving from patient engagement to patient partnership, however, requires more than a useful document. Framework for change.

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Documentation Drug Development 98