ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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SCIENMAG: Medicine & Health

JUNE 8, 2023

Chilean policies aimed at reining in unhealthy food marketing are succeeding in protecting children from the onslaught of television advertisements (TV ads) for these products, according to new research.

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FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Fierce BioTech

JANUARY 3, 2024

S3 Connected Health Digital health Center for Digital Health Innovative Health Solutions Regulation Resource Type Whitepaper connectedhealth-listing-logo.png Wed, 01/03/2024 - 09:10 Pharma Clinical Data Launches Marketing Special Reports Landing Page Url [link] Byline Sponsored by: S3 Connected Health

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Agency IQ

MAY 28, 2024

BY COREY JASEPH, MS, RAC The British medical device regulator just issued its promised framework on international recognition.

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Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

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BioPharma Drive: Drug Pricing

JULY 9, 2024

On Tuesday, regulators updated the public on their yearslong probe of PBM's business practices. The report faults PBMs for profiting at the expense of patients and independent pharmacists.

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BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel holds a degree in Economics from High Point University and lives in Falls Church, VA.

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE.

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Agency IQ

JANUARY 4, 2024

The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. AgencyIQ takes a look at what this could mean for medical device manufacturers. Fill out the form to read the full article.

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The Premier Consulting Blog

DECEMBER 10, 2024

Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Validation reports are to be included in a marketing application. Following approval, release testing continues on every lot of drug product prior to release into the market.

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The Premier Consulting Blog

JANUARY 22, 2024

In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval. The decision of where to launch first requires careful consideration. Degree of novelty. Therapeutic area.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.

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Fierce BioTech

OCTOBER 15, 2024

A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? swheeler Tue, 10/15/2024 - 19:53 Thu, 11/21/2024 - 13:00 Resource Type Webinar Ben Chapman Duration 60 minutes Join for an insightful webinar on the evolving privacy landscape impacting pharma marketers in 2025.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Fierce BioTech

MAY 22, 2024

So, how can pharmaceutical and biotech companies enter this market, and how can EAPs support and facilitate future successful commercialization? In addition, EAPs can help serve as introductions to the dizzying array of regulations and guidelines in European countries. On Demand Start Date Tue, 06/25/2024 - 12:00

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thought leadership

SEPTEMBER 30, 2024

If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical Evaluation Report. In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER). Let’s get started.

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BioPharma Drive: Drug Pricing

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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The Premier Consulting Blog

OCTOBER 30, 2024

Innovation can also lead to faster time to market by accelerating drug development timelines, strengthening the supply chain, and providing better responsiveness during a public health emergency. The process for an advanced manufacturing technologies designation is outlined below in Figure 2.

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Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Perficient: Drug Development

DECEMBER 16, 2024

Email marketing remains a cornerstone for businesses aiming to connect with their audience effectively in the ever-evolving digital landscape. This blog delves into the features, benefits, and best practices of Email Studio, providing insights into how it can elevate your email marketing strategy.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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Perficient: Drug Development

MARCH 5, 2024

As the new year has begun, the Digital Marketing team at Perficient has identified a number of areas where they expect a continued focus throughout 2024 within their areas of expertise. Learn more about what’s top of mind for experts in Content, Audience Insights, SEO, Paid Media and Digital Marketing Strategy below.

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 3D rendering of Antibody Drug Conjugate Molecules.

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Perficient: Drug Development

NOVEMBER 22, 2023

People love superlatives In an HCIC keynote session, John Youshaei, Forbes writer and former marketing lead at YouTube and Instagram, explored core principles of writing for a consumer audience, especially on social channels. So, without further adieu, here are our top insights from HCIC 2023. 1.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.

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Perficient: Drug Development

NOVEMBER 1, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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BioPharma Drive: Drug Pricing

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA also directed manufacturers to produce detailed marketing plans. Yet… Petitioners filed PMTAs for their flavored nicotine liquids, which included marketing and sales access restriction plans, with FDA before the deadline.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.”

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

The announcement also states that FDA expects most future companion diagnostic and infectious disease IVDs would be regulated as class II devices, even if they are novel and require de novo classification. And as we note in that earlier blog , there is good reason to believe all of the above numbers are gross underestimates.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). UV-328 is used in a wide range of applications as a UV absorber and stabilizer.

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