Pharmaceutical Technology

AUGUST 15, 2023

A deep understanding of regional differences in regulations and marketing is critical for global launches.

Packaging 130

Packaging Packaging Marketing Regulation 130

Fierce Pharma

OCTOBER 7, 2024

After winning a first-in-class nod for its two-drug inhaler Airsupra l | After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is bolstering the rescue treatment’s clinical package with new data showing it can cut the risk of asthma exacerbations regardless of patients’ disease severity.

Regulation 111

Regulation Packaging Packaging Trials 111

pharmaphorum

APRIL 11, 2024

The European Parliament has voted through reforms to legislation regulating the pharma sector, which the industry claims could compromise competitiveness and patient care.

Packaging 105

Packaging Packaging Regulation 105

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.

Regulation 98

Regulation Drugs Manufacturing Production 98

XTalks

OCTOBER 7, 2022

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.

Packaging 97

Packaging Packaging Manufacturing Production 97

Pharma Packaging Solutions

NOVEMBER 4, 2024

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. At Tjoapack, we are a leading provider of blister packaging solutions designed to meet the unique needs of the pharmaceutical industry.

Contract Packaging 52

Contract Packaging Packaging Packaging Compliance 52

Pharma Packaging Solutions

JULY 17, 2023

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)

Packaging 52

Packaging Packaging Containment Regulation 52

Pharma Packaging Solutions

NOVEMBER 8, 2024

Medical device packaging plays a key role in ensuring the safety, efficacy, and integrity of medical devices from the point of manufacture to the end-user. At Tjoapack, we are a premier provider of top-tier medical device packaging services. The packaging must adhere to guidelines set by authorities such as the FDA and EU GMP.

Packaging 52

Packaging Packaging Pharma Packaging Compliance 52

pharmaphorum

DECEMBER 22, 2024

Proposed reforms to the regulations for PBMs were dropped from the US Congress' end-of-year bill to provide funding to the federal government

Packaging 75

Packaging Packaging Regulation 75

Pharma Packaging Solutions

AUGUST 2, 2022

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.

Packaging 52

Packaging Packaging Pharma Packaging Regulation 52

XTalks

SEPTEMBER 24, 2020

In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Related: FDA Issues First Injunction of its Product Safety Rule. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

Regulation 94

Regulation Hormones Containment Packaging 94

pharmaphorum

JUNE 10, 2021

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. .

Packaging 52

Packaging Packaging Manufacturing Pharma Packaging 52

Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

Packaging 69

Packaging Packaging Pharma Packaging Manufacturing 69

pharmaphorum

AUGUST 17, 2020

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?

Regulation 97

Regulation Marketing Sales Branding 97

Drug Patent Watch

FEBRUARY 19, 2025

Quality Assurance is a team effort : From manufacturers to regulators, QA professionals, and beyond, everyone plays a critical role in ensuring the quality and safety of generic drugs. So, I ask you: What do you think is the most important aspect of Quality Assurance in the generic drug industry?

Generic Drugs 92

Generic Drugs Drugs Contamination Manufacturing 92

Pharmaceutical Commerce

OCTOBER 17, 2023

Value is attributed to the rise in counterfeit cases and ongoing regulations surrounding anti-counterfeit packaging.

Packaging 52

Packaging Packaging Regulation Marketing 52

STAT News

DECEMBER 23, 2022

trillion omnibus spending package that includes numerous provisions aimed at addressing the opioid epidemic. These highly regulated facilities are made up of multidisciplinary teams of physicians, nurses, counselors, and social workers who provide comprehensive medication-assisted treatment. Congress is expected to pass a massive $1.7

Pharmacy 111

Pharmacy Packaging Packaging Nurses 111

XTalks

JUNE 20, 2024

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.

Packaging 59

Packaging Packaging Protein Manufacturing 59

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). This will benefit both the FDA and the sponsor in a win-win situation.

Production 206

Production Regulation Drugs Development 206

Outsourcing Pharma

JANUARY 3, 2023

The company aims to reduce the single-use plastics utilized in packaging across the pharma industry and has received funding to expand its business.

Packaging 52

Packaging Packaging Regulation Marketing 52

Pharmaceutical Technology

JUNE 19, 2023

Regulations can be challenging, with ever-changing rules. For example, the UK Government has recently announced a series of new measures that will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), representing the biggest overhaul in UK clinical trial regulations in over 20 years.

Medicine 130

Medicine Production Packaging Packaging 130

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.

Packaging 52

Packaging Packaging Manufacturing Production 52

Roots Analysis

AUGUST 26, 2024

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.

Packaging 40

Packaging Packaging Production Manufacturing 40

STAT News

OCTOBER 19, 2022

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.

Packaging 98

Packaging Packaging Containment Regulation 98

Camargo

AUGUST 11, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. Meeting Package Due. Meeting Type. Meeting Purpose. Meeting Timing 1. from receipt of request).

Production 230

Production Packaging Packaging Development 230

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.

Packaging 52

Packaging Packaging Production Sales 52

Pharma Mirror

FEBRUARY 6, 2024

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 recent years, European regulators have supported the The post RWE’s Impact on Product Lifecycle for Biopharma Startups appeared first on Pharma Mirror Magazine.

Production 100

Production Packaging Packaging Clinical Research 100

XTalks

MAY 16, 2024

Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Subscribe to the Xtalks Food Podcast to never miss a new episode.

Regulation 52

Regulation Contamination Packaging Packaging 52

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 US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

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? The new organic food regulations will help reassure consumers that when a label says “organic,” the product is organic.

Regulation 52

Regulation Production Bacteria Packaging 52

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.

Packaging 98

Packaging Packaging Production Development 98

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).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

Camargo

MAY 2, 2021

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. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

XTalks

JANUARY 17, 2023

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. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

Allergies 98

Allergies Packaging Packaging Containment 98

Camargo

JANUARY 12, 2022

While this type of meeting was previously limited to discussions of products regulated by the Center for Biologics Evaluation and Research (CBER), INTERACT meetings will also encompass those regulated by the Center for Drugs Evaluation and Research (CDER) under PDUFA VII. Receipt of Background Package. Response Time.

Production 169

Production Gene Therapy Packaging Packaging 169

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.

Regulation 45

Regulation Production Cosmetics Sales 45