pharmaphorum

JULY 17, 2024

Discover how artificial intelligence is revolutionising drug development and compliance in the pharmaceutical industry with these four impactful ways.

Compliance 111

Compliance Development Drugs 111

Drug Patent Watch

DECEMBER 11, 2024

The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance.

Generic Drugs 98

Generic Drugs Development Drugs Compliance 98

Pharma Mirror

NOVEMBER 7, 2023

Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. In the United States, for example, the Food and Drug Administration (FDA) plays a central role, while the European Medicines Agency (EMA) oversees regulations in the European Union.

Compliance 130

Compliance Regulation Production Manufacturing 130

ACRP blog

JANUARY 28, 2025

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR).

Compliance 59

Compliance Research Clinical Trials Clinical Trials 59

Drug Patent Watch

DECEMBER 10, 2024

This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers. In this article, we will delve into the benefits of working with integrated CDMO services and explore how they can streamline the drug development and manufacturing process.

Manufacturing 96

Manufacturing Development Drugs Compliance 96

Drug Patent Watch

OCTOBER 24, 2024

The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. Food and Drug Administration… Source

Generic Drugs 100

Generic Drugs Drugs Compliance Regulation 100

XTalks

NOVEMBER 6, 2024

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Across the industry, recent innovations in drug delivery signal a creative shift towards ease of administration and expanded treatment options.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

Compliance 105

Compliance Manufacturing Life Science Production 105

Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. The cost of producing generic drugs is influenced by a multitude of factors, and understanding these dynamics can help us better appreciate the affordability of these essential medications. Let's start with the basics.

Generic Drugs 78

Generic Drugs Production Compliance Drugs 78

Pharmaceutical Technology

OCTOBER 10, 2024

At CPHI Europe, an expert discussed the promise of gummies as a drug delivery system and their unique manufacturing challenges.

Drug Delivery Systems 130

Drug Delivery Systems Drug Delivery Compliance Drugs 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 8, 2023

Computational chemistry is today very much required for pharmaceutical compliance including prediction of toxic behaviour of nitrosamine for drug safety, according to experts. Identification and determination of toxic behaviour of a molecule is one of the most difficult challenges faced in ensuring drug safety.

Compliance 189

Compliance Drugs Clinical Trials Clinical Trials 189

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production 188

Production Clinical Trials Clinical Trials Compliance 188

Pharma Marketing Network

MARCH 6, 2025

This article explores effective social media advertising strategies tailored for pharmaceutical marketing executives , helping them navigate compliance and create impactful campaigns. Patients trust online communities for treatment discussions, symptom management, and drug reviews. but not in the EU.

Compliance 52

Compliance Branding Marketing Regulation 52

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

Generic Drugs 92

Generic Drugs Drugs Contamination Manufacturing 92

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

Drug Patent Watch

DECEMBER 10, 2024

Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy. They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs.

Compliance 98

Compliance Manufacturing Production Regulation 98

Bio Pharma Dive

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

Generic Drugs 152

Generic Drugs Compliance Drugs 152

Pharmaceutical Technology

OCTOBER 28, 2024

Ahead of the upcoming DSCSA November deadline, pharma companies reimagine track-and-trace to tackle the US counterfeit drug landscape.

Compliance 130

Compliance Pharma Companies Drugs 130

Pharmaceutical Commerce

OCTOBER 11, 2024

The now-11-year odyssey to track drugs by item through the supply chain will be under a regulatory exemption for up to two years.

Compliance 111

Compliance Drugs 111

Pharmaceutical Technology

AUGUST 22, 2022

Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. The post Compliance to convenience: understanding the latest innovations in capsule formulation appeared first on Pharmaceutical Technology. To find out more about Procaps softgels, download the whitepaper.

Compliance 130

Compliance Bioavailability Containment Branding 130

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 12, 2024

In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.

Compliance 188

Compliance Regulation Drugs Clinical Trials 188

pharmaphorum

FEBRUARY 14, 2024

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

Development 129

Development FDA Approval Drugs Compliance 129

Pharmaceutical Technology

JUNE 29, 2022

The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale. The post Enabling the next wave of innovative drug therapies with speciality enzymes appeared first on Pharmaceutical Technology.

Drugs 295

Drugs Gene Therapy Production Manufacturing 295

Drug Patent Watch

MARCH 17, 2025

Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? Or perhaps you're a healthcare professional interested in understanding the intricacies of generic drug launches? So, what makes a generic drug launch successful?

Generic Drugs 52

Generic Drugs Drugs Compliance Marketing 52

Cloudbyz

APRIL 25, 2023

Pharmacovigilance plays a pivotal role in safeguarding patients from potential adverse effects and ensuring the safety of drugs and medical devices. These reports provide essential information on the safety profile of drugs and medical devices, enabling regulatory authorities to monitor their safety and take appropriate action when necessary.

Compliance 97

Compliance Clinical Trials Clinical Trials Manufacturing 97

Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This groundbreaking approach can help tailor medical treatments to an individual’s genetic makeup, considerably enhancing drug efficacy and safety while minimizing adverse drug reactions.

Medicine 182

Medicine DNA Compliance Clinical Trials 182

Cloudbyz

JUNE 16, 2023

Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Purpose of Clinical Trial Data Archiving: Compliance: Regulatory authorities require clinical trial data to be retained for a specific duration to demonstrate compliance with guidelines and regulations.

Clinical Trials 94

Clinical Trials Clinical Trials Compliance Trials 94

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing 96

Licensing Licensing Branding Drugs 96

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. Food and Drug Administration (FDA). This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials.

Clinical Trials 98

Clinical Trials Clinical Trials Compliance Trials 98

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

Generic Drugs 52

Generic Drugs Bioequivalency Development Drugs 52

Cloudbyz

SEPTEMBER 12, 2024

In clinical trials, ensuring data quality is crucial for both the success of the trial and regulatory compliance. By discussing sophisticated use cases and best practices, we offer an in-depth perspective on how to implement effective edit checks for maximal data accuracy, compliance, and efficiency. Core Types of Edit Checks 1.

Compliance 96

Compliance Clinical Trials Clinical Trials Trials 96

Pharma Marketing Network

FEBRUARY 19, 2025

This guide explores the best strategies for boosting engagement while ensuring compliance , helping pharma brands connect with their audiences more effectively. Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations.

Compliance 72

Compliance Marketing Branding Regulation 72

FDA Law Blog

JANUARY 10, 2023

20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). We are inclined to agree, given that the new Guidance applies to all products making health-related claims, including food, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.

Compliance 105

Compliance Production In-Vitro Drugs 105

Pharmaceutical Technology

JULY 21, 2022

The drug combination is anticipated to be made available in August and could only be used in compliance with the necessary conditions of the Swiss Society of Infectious Diseases (SSI). Currently, the drug combination is offered for preventive usage and the federal government reimburses it.

Antibody 264

Antibody Compliance Clinical Trials Clinical Trials 264

Pharma Mirror

JANUARY 5, 2024

New Delhi, India – FD-AID, LLC, a distinguished leader in pharmaceutical quality and compliance solutions, proudly announces its entry into the Indian pharmaceutical market.

Compliance 130

Compliance FDA Compliance Marketing Drugs 130

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105