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The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.
This article explores the key metrics pharma marketing teams should prioritize to drive success. Unlike traditional consumer brands, pharmaceuticalcompanies face unique challenges on social media, including strict regulations, compliance concerns, and the need for factual accuracy.
Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Implementing Pharmaceutical Quality systems.
Despite untold investment by numerous pharmaceuticalcompanies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.
In this article, we’ll explore 10 innovative trends in pharma marketing that can set you up for success in this rapidly evolving landscape. Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries. Learn more about compliance tips at Pharma Marketing.
But because they’re dietary supplements, they’re not regulated by the FDA. What pharmacists should know about the blockbuster drugs of 2023 Blockbuster drugs are medications that generate significant annual revenue ($1 billion or more) for pharmaceuticalcompanies. Read more here. Read more here.
Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.
This article explores the evolving role of referral marketing in pharma, unpacking its mechanics, benefits, compliance considerations, and future outlook. On the patient side, pharmaceuticalcompanies have launched ambassador and mentorship programs. How do pharma companies use referral marketing?
The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. Innovation will power the market. Difficile treatment, Ser-109.
The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceuticalcompanies. In this article, well take a closer look at semaglutide, its costs, and alternatives that may be offered.
This article explores how to develop and optimize paid social media campaigns that drive engagement while staying compliant. Disease awareness campaigns can also reach specific patient groups based on demographics and interests, helping pharmaceuticalcompanies create more personalized outreach. In the U.S.,
In this article, well dive into key pharma digital marketing strategies that can help pharma brands connect with healthcare professionals (HCPs), patients, and stakeholders effectively. Using FDA-approved messaging and ensuring transparent disclaimers are critical in avoiding regulatory issues. However, compliance is key.
However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.
In my last article, I outlined the inflection point facing the pharmaceutical industry in digital health and the digital transformation of its clinical and commercial operations. This time I’m going to focus on one company and its view on pharma’s digital commercial strategy. Digital fluency and change.
This article will explore the advantages of using HCs, as well as several considerations for their effective use, including scientific methodology and regulatory guidance. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceuticalcompanies in Europe, Canada, the United States and Asia.
Patents are often described as the ‘lifeblood’ of pharmaceuticalcompanies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Letter to FDA, 06 July 2022.
Applying what has been learned over the last three years to update pharmaceuticalcompanies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. President, U.S. Business Unit and U.S. Country Head.
In the digital age, content creation for social media has become an indispensable tool for industries across the board, including pharmaceuticals. As the healthcare landscape evolves, pharmaceuticalcompanies are increasingly leveraging social media platforms to connect with healthcare professionals, patients, and the broader public.
One of the key areas of expertise for Pharma-Mkting.com is pharmaceutical marketing. They provide a comprehensive range of services and resources to help pharmaceuticalcompanies reach their target audience and achieve their marketing goals. This article was produced with the assistance of artificial intelligence.
The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. Second, pharmaceuticalcompanies can implement serialisation of individual medicines, potentially tracking and tracing medicines to ensure brand protection. About the author.
This is an especially tough predicament for pharmaceuticalcompanies given the need to target very specific audiences while maintaining reach. For pharmaceuticalcompanies, this need is even more pressing. Premium Placement Quality Allows Creative to Shine.
“Picking the next merger candidate is hard enough, doing so before everyone else jumps on board, then picking the right time to sell makes for a dangerous investment game,” said one BBC News article from December 1998. However, this new name has since caused confusion between Prilosec and Prozac. Blockbusters go off patent.
The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. In recent years, several drugs for Alzheimer’s have been developed, but none have been able to gain approval from the FDA. FDA Approves Leqembi for the Treatment of Alzheimer’s Disease.
Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceuticalcompanies must adhere to strict regulations while also developing creative and effective marketing campaigns.
The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. 7 also in the scheme of microbial monitoring.
Farxiga is an oral prescription drug containing the active ingredient dapagliflozin and made by the pharmaceuticalcompany AstraZeneca. The initial FDA approval of Farxiga for heart failure was for people with heart failure with a reduced ejection fraction. It is classified as a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Pharmaceutical marketing is not just about reaching healthcare professionals and patients; it involves a complex interplay of understanding market dynamics, regulatory compliance, and leveraging digital platforms. Failure to comply with these regulations can result in severe penalties, including fines and reputational damage.
This article is the first part of three and covers the first three of nine predictions, here focusing on global healthcare environmental challenges and what they mean for the pharmaceutical industry. More remains to be addressed, and not just by conventional pharmaceuticalcompanies. Pharma’s starting to wake up to this.
The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Tue, 11/01/2022 - 06:49.
For pharmaceuticalcompanies there are a number of implications. For pharmaceuticalcompanies, this may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings. It will take a decade to fully evaluate the true impact. The non COVID-19 patient backlog.
This means that drugs such as Keytruda, which has received almost 40 FDA approvals since its launch, can offer significant volume-based rebates. The Life Sciences Practice works with leading biotech, medical device, and pharmaceuticalcompanies; law firms; regulatory agencies; and national and international industry associations.
Pharmaceuticalcompanies have made major strides in developing new treatments for Alzheimer’s disease, offering hope for the millions of people affected by this debilitating condition. Food and Drug Administration (FDA) in June 2021. 2021, June 7). Retrieved from [link] · What is Alzheimer’s disease?
The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb].
The article focuses on the integration of automation with Artificial Intelligence (AI) and Machine Learning (ML). This article provides an informative account of intelligent automation, the key differences between AI & ML, their importance, and a potent eight-step roadmap to implementation. With the impelling Pharma 4.0,
This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. FDA, Computer Software Assurance for Production and Quality System Software – Draft Guidance. FDA, 2022. . The GAMP 5 Second Edition includes: Six completely new appendices. About the authors.
This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.
It is a biologic medication and monoclonal antibody made by the pharmaceuticalcompany Janssen Biotech. Stelara is an injectable prescription drug containing the active ingredient ustekinumab. Stelara works by blocking proteins in the immune system that cause inflammation.
NB: in Part I of this article, notions of lower-pricing intentionality and comparative global opportunities were explored. The Life Sciences Practice works with leading biotech, medical device, and pharmaceuticalcompanies; law firms; regulatory agencies; and national and international industry associations.
The parties that benefit are the pharmaceuticalcompanies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. The FDA does virtually no testing.
Pharmaceuticalcompanies have made major strides in developing new treatments for Alzheimer’s disease, offering hope for the millions of people affected by this debilitating condition. Food and Drug Administration (FDA) in June 2021.
Pharmaceuticalcompanies have long taken notice of this opportunity, developing a wave of therapies that are now entering the market. FDA data indicates that while the number of orphan designations has been increasing over the last half-decade, the number of unique indications has been decreasing 3.
This article provides a comprehensive overview of the various facets of pharmaceutical marketing, from its historical evolution to future trends. By understanding these strategies, stakeholders in the pharmaceutical industry can better navigate the complexities of promoting their products effectively.
This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. By adhering to critical process parameters (CPPs), pharmaceuticalcompanies can avoid legal and financial risks while building trust with patients in the safety and reliability of their products. Keep on reading!
The drug lecanemab ( Leqembi ) was recently approved by the FDA to treat early Alzheimer’s disease. Pharmaceuticalcompanies do not know what to make of this unexpected complication. is moderate dementia and a score of 16-18 is really severe Alzheimer’s disease. Put another way, the lower the score the better.
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