XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

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Regulation Hormones Containment Packaging 94

Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

Development 97

Development Regulation Compliance Containment 97

Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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Marketing Compliance Production Doctors 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Finding the best commercial packaging suppliers in contract marketing.

Packaging 100

Packaging Packaging Marketing Containment 100

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

Clinical Trials 126

Clinical Trials Clinical Trials Trials Clinical Research 126

Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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Contamination Manufacturing Containment Production 130

XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

Contamination 105

Contamination Compliance Regulation Production 105

Camargo

SEPTEMBER 14, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

Clinical Trials 144

Clinical Trials Clinical Trials Medicine Production 144

Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

Regulation 52

Regulation Compliance Contamination Marketing 52

FDA Law Blog

FEBRUARY 13, 2025

While a PCCP can address many types of post-market device changes, FDA specifically recognizes that software development is an iterative process, and software developers continually try to improve and update devices.

Manufacturing 71

Manufacturing Marketing Development Containment 71

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Regulation Compliance Medicine Manufacturing 52

The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

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Development Regulation Medicine Containment 75

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

Packaging 98

Packaging Packaging Containment Production 98

Pharmaceutical Technology

MAY 24, 2023

The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Regulation 45

Regulation Production Cosmetics Sales 45

pharmaphorum

JUNE 16, 2021

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. They point out that consumers can make it more difficult to be tracked by disabling advert identifiers, adjusting app permissions, and using advert blockers.

Containment 145

Containment Regulation Research Development 145

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R. Design controls (21 C.F.R.

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Compliance Marketing Regulation Development 98

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. The vaccine is top of the list of 35 potential coronavirus vaccines in clinical development, according to a list maintained by the World Health Organization.

Vaccination 104

Vaccination Vaccine Trials Protein 104

World of DTC Marketing

MAY 24, 2022

In a review of 52 apps for anxiety , an international team of psychologists found that sixty-seven percent had been developed without any guidance from a healthcare professional. It means that mental help apps and services must be tightly regulated and reviewed. Does this mean we should give up?

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Licensing Licensing Scientist Production 252

XTalks

OCTOBER 13, 2023

The magic lies in its patented De-Sugaring technology developed by NTFC. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Impressively, this sugar free cranberry juice retains every bit of the fruit’s nutritional value. Sugar is ubiquitous.

Containment 105

Containment Production Marketing Branding 105

XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

Containment 96

Containment Hormones Contamination Packaging 96

Pharmaceutical Technology

FEBRUARY 16, 2023

Stringent government regulations and the growing need for uncompromised quality have further encouraged demand. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Engineer 130

Engineer Manufacturing Containment Production 130

Pharmaceutical Technology

APRIL 18, 2023

The companies help to design, develop and scale marketing strategies to effectively transition into a digitalised future. The companies help to design, develop and scale marketing strategies to effectively transition into a digitalised future.

Regulation 130

Regulation Production Marketing Containment 130

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness 2 ,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.

Clinical Development 52

Clinical Development Medicine Development Containment 52

Camargo

MAY 19, 2021

The HUD designation provides an incentive for sponsors developing medical devices to be used in the treatment or diagnosis of diseases affecting small populations. CFR – Code of Federal Regulations Title 21. Timeline and Maintenance. The FDA should respond to the request within 45 days. Author: Marissa Berry, PhD, RAC.

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Production FDA Approval Marketing Drugs 142

WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. If the objectives of the study contain a health claim the substance being studied will be considered a drug and the FDA likely will require an IND.

Regulation 40

Regulation Research Production Compliance 40

XTalks

JANUARY 12, 2022

“One of the most efficient ways to enhance food safety and reduce spoilage and waste is to develop efficient biodegradable non-toxic food packaging materials.”. According to the US Environmental Protection Agency (EPA), plastic containers and packaging make up a major portion of municipal solid waste, accounting for 82.2

Packaging 98

Packaging Packaging Scientist Bacteria 98

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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In-Vitro Regulation Manufacturing Licensing 81

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. Timely intervention is imperative to contain and mitigate potential impact.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

The Pharma Data

NOVEMBER 2, 2020

The biotechnology production development program commenced in October 2020 with completion expected in September 2021. “Our goal is the development of precise and predictable psychedelic drug formulations for clinical study and therapeutic use.” “Psychedelic agents are a promising new class of therapeutic drug.

Production 52

Production Development Drug Delivery Drugs 52

pharmaphorum

MAY 5, 2022

We develop and advance data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a powerful framework for generating clinical research data that is as accessible as it is illuminating” ( CDISC , 2021).

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

XTalks

AUGUST 26, 2024

Supermarket baby food is often a critical aspect of early childhood development. A recent study published in the journal Nutrients highlights significant concerns, revealing that many baby foods contain excessive amounts of sugar and salt, coupled with misleading marketing claims.

Containment 52

Containment Production Regulation Protein 52