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To combat food poisoning, US agriculture officials introduced a final rule last Friday, mandating significant reductions in Salmonella bacteria in specific chicken products. Starting in 2025, high levels of Salmonella in frozen breaded and stuffed chicken products will classify them as adulterated. How Common Is Salmonella in Chicken?
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.
Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.
Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging?
As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Such products require more complex target profiling. Such products require more complex target profiling. Definition of Combination Products.
It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding. In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle.
As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. Confusion around date codes on food packaging is often cited as a contributor to food waste across the US and globally. So, will this trend emerge in the US?
In the complex world of pharmaceutical packaging, selecting the right blister packaging supplier is a critical decision that can significantly impact product presentation, protection, and compliance. Material Selection Central to the blister packaging process is the selection of appropriate materials.
The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.
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. General Regulations (From Section 112.1) General Regulations (From Section 112.1)
Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.
Related: FDA Issues First Injunction of its Product Safety Rule. In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Another part of the problem, according to the petition, is the Generally Recognized As Safe (GRAS) law.
According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.
If you have ever taken any kind of medication, be it prescription or over the counter (and you almost certainly have), then you’re probably familiar with blister packaging. Blister packaging is extremely common in the pharmaceutical industry, thanks to its many benefits. Another benefit of blister packaging is convenience.
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry. Request business program via the link. .
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. The meeting has several goals: Discuss issues critical to early product development.
In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?
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.
After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.
It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.
As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. Receipt of Background Package. Response Time. calendar days).
This rule would mandate front-of-package nutrition labeling, which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. Also in this episode, Sydney talks about The US Food and Drug Administration’s (FDA) new requirement for prepackaged foods in the US.
The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.
Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. The process eliminates the disadvantages of conventional drying methods or freezing.
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.
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.
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.
SUS provides full, free and universal access to healthcare for the country's entire population (215 million), which spends around 10% of its gross domestic product (GDP) on healthcare. Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture.
is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. According to the recall announcement that was posted by the US Food and Drug Administration (FDA), Sagent says the issue affects reserve sample vials that could lead to a non-sterile product.
Contract manufacturing organizations (CMOs) are critical to ensuring the adequate and timely production of drugs and are involved in each step of the way. While the Lonza Group and Samsung Biologics are manufacturing the biological API, the latter is also in charge of the parenteral manufacture and packaging. NICE decisions.
In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.
The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.
The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.
Also in this episode, Sydney talks about a new rule implemented by the US Department of Agriculture (USDA) that mandates lower Salmonella levels in frozen breaded and stuffed chicken products. Starting in 2025, poultry producers will be required to decrease Salmonella to very low levels in targeted chicken products.
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. I don’t sell medical products.”
She discusses some of the latest developments in technology that businesses are adopting to remove PFAS from their products and processes. Cally also talks about what consumers can do to minimize their exposure to PFAS, as well as how she foresees the role and presence of PFAS in the food industry evolving in the next five to ten years.
Focusing on the law: “Regulators moved quickly to simplify rules across the clinical trial supply chain…the use of public transport to move people, and postal services to move medicinal products around the country has been adopted,” according to Ievgenii Volynets, head of commercial legal at international clinical trial logistics provider Oximio.
This rule would mandate front-of-package nutrition labeling , which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. The idea of front-of-package nutrition labeling is not new since many countries already use this system.
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?
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.
Food and Drug Administration is alerting the public that several categories of FDA-regulatedproducts purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Families rely on stores like Family Dollar for products such as food and medicine.
Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Because of the significant public health need, FDA granted this 505(b)(2) pathway product a fast track designation in late 2017.
However – particularly in rare disease programs with only one Phase 3 trial, often of short duration – sponsors many times find themselves ready to file clinical data before completing the minimum 12 months of stability testing on the to-be-marketed finished product and API. Having a quality agreement in place is critical. Pediatric Plan.
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