The FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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ISPE

MARCH 16, 2023

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. Automated systems offer a range of options for pharmaceutical companies. This also results in significant cost savings and increased efficiency.

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ISPE

SEPTEMBER 15, 2023

Special Highlight: Keynote Session with FDA's Commissioner Robert M. Califf, MD Commissioner of Food and Drugs FDA We are thrilled to announce that Robert M. Califf, MD, Commissioner of Food and Drugs at the FDA will be joining ISPE during the 2023 ISPE Annual Meeting & Expo.

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Pharma Marketing Network

MAY 3, 2023

First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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ISPE

MARCH 6, 2023

Trudy Patterson Mon, 03/06/2023 - 11:50 iSpeak Blog iSpeak Operations Data Challenges Limit the Value Realized from Pharma 4.0 Michael Krause 6 March 2023 Pharmaceutical and biotech portfolios continue to transition from high volume blockbusters to a diversified set of lower volume, targeted therapeutics.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Pharma Marketing Network

JULY 10, 2023

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 pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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The FDA Law Blog

AUGUST 22, 2023

In January this year, six months after the last enforcement letter from OPDP, we blogged on a decision from the National Advertising Division (NAD) about misleading claims made in Rx drug promotion. NAD appeared to be inviting pharmaceutical companies to leverage its processes and submit complaints.

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Roots Analysis

MARCH 26, 2024

However, the road for transition from the conventional batch to continuous manufacturing requires a shift in variety of parameters and is still quite unclear to many of the pharmaceutical companies. As a result, many success stories have come into the light which involves continuous manufacturing of a drug.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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Roots Analysis

APRIL 20, 2022

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. Further, studies indicate that more than 100,000 tons of pharmaceutical products are consumed globally per year. 3] Some of the advantages offered by pharmaceutical secondary packaging have been depicted below. trillion in 2023.

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Roots Analysis

SEPTEMBER 4, 2023

Despite the challenges, several service providers have served as resourceful partners and successfully led the development and commercial launch of multiple companion diagnostic devices; for instance, Labcorp has supported the development of 19 FDA-cleared companion diagnostic devices.

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Roots Analysis

APRIL 15, 2024

In order to ensure that this critical aspect is maintained, the pharmaceutical company should carry out a detailed evaluation of the quality control and quality assurance departments of the CMO partner. Chances of de-prioritization: Usually, CMOs are involved in multiple projects and agreements with different pharmaceutical companies.

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Roots Analysis

AUGUST 1, 2024

GLP-1 receptor agonist market have captured the attention of both large and small pharmaceutical companies, for more than a decade. Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA.

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Viseven

APRIL 11, 2023

This may include blog posts, whitepapers, videos, podcasts, or infographics. The most suitable formats for pharma are eDetailers, infographics, case studies , blog posts, articles, and so on. For example, blog articles and social media posts may be most effective during awareness.

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ISPE

NOVEMBER 28, 2022

ISPE Advancing Pharmaceutical Quality Program Complete. iSpeak Blog. ISPE Advancing Pharmaceutical Quality Program Complete. ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide. Trudy Patterson. 28 November 2022.

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Roots Analysis

AUGUST 26, 2024

Further, pharmaceutical companies are also becoming cautious towards optimizing various operations for packaging, which can indirectly help in reduction of raw material and energy consumption.

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Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

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Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.”

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Pharma Marketing Network

JUNE 11, 2020

RJ Lewis (EHS): So today everybody’s a publisher, part of the beauty of the web and even if you don’t have the technical skills for firing up a website or a blog, which is pretty easy. So whether you’re an advertiser or an event coordinator or a supplier in the industry, most of them have pretty active blogs.

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Roots Analysis

OCTOBER 29, 2023

It is worth noting that in order to continue clinical research parallel to COVID related restrictions, the US FDA guidelines released in March 2020, allowed sponsors to conduct virtual visits, remote patient monitoring, and telephonic interviews.

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Pharma Marketing Network

JUNE 11, 2020

I landed on John Mack’s blog, as I’ve done many, many times in the past to look up something. What do you what are you doing with the blog? Yeah, I even wanted to wear the shirt to this FDA meeting. Plus, I don’t think… I don’t know how the FDA would respond to Hawaiian shirt.

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ISPE

NOVEMBER 1, 2022

iSpeak Blog. 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.

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Pharma Marketing Network

MAY 11, 2023

Pharmaceutical companies 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?

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ISPE

NOVEMBER 2, 2022

iSpeak Blog. Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. 2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward.

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The FDA Law Blog

DECEMBER 18, 2023

The letters come on the heels of FDA finalizing its Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. FDA argued that the “per act of sex” efficacy claim is not validated. and 5.2 = 3.2) divided by the average baseline score of 27 to get 11.85%. and 5.2 = 3.2)

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Omnicell

JANUARY 10, 2023

In this most recent EO, the President targeted not one, but three of the largest sectors of healthcare—hospitals, health plans, and pharmaceutical companies. There has been wide speculation as to just how aggressive the Biden Administration would be in effecting health policy change over the next four years.

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The FDA Law Blog

MAY 26, 2025

And the memo goes one step more arguing that, even if otherwise truthful, promotion of off-label uses of hormones can run afoul of FDA prohibitions on misbranding and mislabeling.

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