Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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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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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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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

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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Outsourcing Pharma

NOVEMBER 10, 2021

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

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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

FEBRUARY 13, 2024

However, the line between enticing marketing and misleading information can sometimes blur, leading to controversies and legal actions. This dynamic has propelled misleading advertisement lawsuits into the spotlight, with several high-profile cases raising questions about the integrity of food marketing and its impact on consumer trust.

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XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

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Pharmaceutical Technology

JULY 29, 2022

Once new vaccines for the Omicron variant are approved, they will partly make up for the waning interest in older Covid boosters in developed markets. This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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Pharmaceutical Technology

APRIL 14, 2023

The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label. The company is expecting regulatory decisions for the drug in additional markets across the world this year.

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Pharmaceutical Technology

NOVEMBER 30, 2022

These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. The EMA had provided a positive opinion for this marketing authorization back in July. Regulatory decisions come in. NICE decisions.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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XTalks

APRIL 24, 2023

The natural mold inhibitor is just the latest in Corbion’s wide range of offerings, which include food innovations, specialty ingredients and packaging products. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging? Here’s everything you need to know about this burgeoning food industry innovator.

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.

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BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

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BioPharma Reporter

APRIL 3, 2024

Pluss, a leading provider of temperature-controlled packaging solutions, today (April 3) launched its latest innovation, the Celsure XL VIP pallets.

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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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pharmaphorum

NOVEMBER 11, 2022

Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully.

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Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

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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. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

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Camargo

OCTOBER 20, 2021

From the regulator’s point of view, combination products are not restricted to combined biologics, drugs, and/or devices formed into a single entity (like a drug-eluting coronary artery stent). CMC and Post-Marketing. This will benefit both the FDA and the sponsor in a win-win situation.

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Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. PRIME is an EMA scheme to support the development of medicines for rare diseases and conditions with high unmet need.

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Cloudbyz

MARCH 3, 2023

To address this challenge, mid-size CROs should invest in marketing and branding to increase their visibility and differentiate themselves from their competitors. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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XTalks

DECEMBER 19, 2023

It’s a stark reminder of the varying food safety and health regulations that exist worldwide. It’s a tale of innovation, consumer preferences and the challenges of introducing alternative sweeteners to a market dominated by traditional tastes. What Ever Happened to Coke with Stevia?

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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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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or.

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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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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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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com.

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pharmaphorum

DECEMBER 20, 2021

The pair touch on the regulatory changes over the last 18 months, and Sai gives his take on the future of regulations in different countries and whether the current momentum in the market will be maintained. Sai has 20 years of product development and business strategy experience in the pharmaceutical industry. About the author.

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FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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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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XTalks

JANUARY 11, 2021

The word “sustainable” often gets tossed around in the food and beverage industry, with companies making certain claims about their products to market themselves as the better option. From sustainably-grown fruits and vegetables to sustainably-sourced coffee beans — not to mention sustainable packaging — what does it all mean?

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