FDA Law Blog

MARCH 2, 2022

By Riëtte van Laack — On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo.

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. Related: Are Best Before Dates on Food Packaging to Blame for Food Waste? According to a recent report from The Business Research Company, the global organic food market is projected to reach $294.54

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. 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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XTalks

FEBRUARY 13, 2024

Food advertisements play a crucial role in shaping consumer choices, influencing dining habits and driving sales. However, the line between enticing marketing and misleading information can sometimes blur, leading to controversies and legal actions.

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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. According to GlobalData’s patient-based forecast model, Stelara is anticipated to have US sales of $525.5m

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Pharmaceutical Technology

MARCH 10, 2023

The pharmaceutical freeze-drying systems market is expected to be driven by the integration of smarter technologies in lyophilisation methods such as electron microscopy, biochemistry, and advancement in surgeries.

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Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. These distinctions are important as they determine the regulatory burden required to market a product in Canada.

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XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal.

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pharmaphorum

DECEMBER 10, 2021

Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe, but has now withdrawn its EU marketing application.

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Pharma Packaging Solutions

DECEMBER 17, 2020

During my thirty fours years in the packaging business, I have realized packaging touches more departments than any other component purchased by our customers. The marketing department is always engaged considering the package is the first impression impacting the customer. Suddenly Made in America is prominent again.

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XTalks

AUGUST 4, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. In this episode of the Xtalks Food Podcast, Sydney talks about the social media-based food scandal, from Pink Sauce’s ingredients to packaging and marketing. While Monster Energy generated about $3.24

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pharmaphorum

APRIL 21, 2021

The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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FDA Law Blog

JULY 19, 2022

Department of Agriculture (FSIS) requesting that FSIS initiate rulemaking to remove animal raising claims from the label approval process because, according to PETA, FSIS has no authority to approve animal raising claims and FSIS is not authorized to regulate on-farm animal raising conditions or activities. So, what is going on?

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Pharma Marketing Network

MARCH 25, 2023

A strong brand identity can help increase recognition and loyalty, and ultimately drive sales. Companies can gather this information through market research and focus groups. This includes everything from the company’s website and social media presence to packaging and advertising. Healthcare Success.

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pharmaphorum

AUGUST 20, 2020

BioMarin previously agreed with the FDA on a data package necessary to support approval, but the company said the regulator has introduced a new recommendation for two years of safety and efficacy data. This data could be generated by the ongoing phase 3 GENEr8-1 trial which uses annualised bleeding rate as a primary endpoint.

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XTalks

MARCH 15, 2022

Mexico City-based Grupo Bimbo has suspended sales of the Bimbo brand in Russia as well as new capital and marketing investments, the company announced yesterday. . CPW sells cereal outside North America with sales in Russia accounting for less than one percent of total General Mills sales.

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Creogenic Pharma

APRIL 15, 2023

Knowledge of which areas are covered by the company and which are still vacant, different types of packaging available, and any unique products that the company offers can also be valuable information to have when communicating with potential franchisee distributors. Regular income with high experience of market working and conditioning.

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XTalks

MAY 24, 2023

The conflict involves the naming rights to “Manuka honey,” a product whose potential health benefits and significant price markup have made it a highly sought-after commodity in the international market. There are also high export costs associated with packaging, exporting and distributing the honey to international markets.

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Pharma Packaging Solutions

JULY 17, 2023

The biopharmaceutical market is ever growing, thanks to constant scientific advancements in the field. As biopharma products become more common, so must biopharma packaging. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution.

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pharmaphorum

AUGUST 12, 2022

Formulate a National Plan – Continuous manufacturing thrives on integration and coordination, making it important to act on a national level with the joint input of regulators and industry leaders. Frédéric Kahn, vice president of Sales, Wavelength Pharmaceuticals. And with continuous manufacturing, the path forward is too.

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XTalks

JUNE 27, 2023

Mislabeling: False information is intentionally placed on the packaging or label, misleading consumers about the product’s true nature. Gray market production/theft/diversion: Unregistered or unauthorized products are illicitly sold, bypassing legitimate distribution channels.

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Pharma in Brief

AUGUST 3, 2023

Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. Key results include: Total revenues increased 5% to $6.5

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Pharma in Brief

SEPTEMBER 1, 2022

These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. A reduced package of Amendments comes into force. In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ).

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Unfortunately, the FedEx package drop-off time is 4:00 pm and the pick-up truck has left for the day. The only way to get the device to the site in time for the procedure is to drop off the device package to the airport. A great project manager would drive to the airport and drop off that package. Want to refer to this later?

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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The Pharma Data

MAY 14, 2021

When you drink, the liver has to work to remove the alcohol from the blood instead of regulating blood sugar. I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST!

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. million of revenue from sales of COVID-19 antibodies.

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XTalks

MARCH 28, 2024

In a statement announcing the approval and describing the mechanism of action of the drug, Merck said Winrevair improves the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH, reversing vascular and right ventricle remodeling. In 2023, sales of Uptravi hit $1.6 billion in 2032.

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Pharma in Brief

DECEMBER 3, 2020

Health Canada has now begun the consultation process to transition drugs, vaccines and medical devices that were authorized under the interim orders to a more permanent market authorization under the relevant regulatory regime. require market authorization holders to meet post-marketing regulatory requirements; and.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. billion in pharmaceutical sales from 2021. billion, a 42.74

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Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. Nor is it unusual for FDA to give FDA a deadline (which is often missed).

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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