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. The amendments contemplate labelling flexibilities for special containers. Food and Drug Regulations , C.R.C., Public Comments.

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Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Cannabis plants and derivatives containing no more than 0.3% This can make research challenging, but not insurmountable.

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BioPharma Reporter

NOVEMBER 24, 2020

Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.

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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.

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The Pharma Data

MARCH 5, 2021

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). Sanofi announces today the filing of its Form 20-F with the U.S. Source link:[link].

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Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry.

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FDA Law Blog

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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The Pharma Data

SEPTEMBER 24, 2020

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study. The team looked through the National Institute of Health’s Dietary Supplement Label Database and the Natural Medicines Database for products containing unapproved drugs. Conor Kavanagh.

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World of DTC Marketing

MAY 24, 2022

While some applications like Talkspace and Betterhelp connect you with a licensed therapist, a substantial portion of the market has gone fully humanless. And the COVID-19 pandemic has likely given the market an added boost, Torous adds. It means that mental help apps and services must be tightly regulated and reviewed.

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Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

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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.

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Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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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).

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Pharma in Brief

AUGUST 5, 2020

DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. GENVOYA is a designated “innovative drug” in respect to TAF pursuant to the data protection provisions of the Food and Drug Regulations , CRC, c 870 ( Data Protection Regulations ). Background. Minister of Health’s Decision.

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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. In this second installment, we compare applications for conducting clinical studies, expedited programs, pediatric plans, and labeling in the US and EU markets.

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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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Delveinsight

OCTOBER 1, 2021

There are several therapies in the market to address the Myasthenia Gravis burden, and many companies are still working on their drug candidates to cope with Myasthenia Gravis. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Myasthenia Gravis Approved Therapies.

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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.

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Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

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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. However, products labeled “organic” may contain five percent non-certified organic materials. When is Food Considered Organic? The USDA has stringent rules for what is considered organic.

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XTalks

JUNE 13, 2024

The market for hemp beverages has been growing rapidly in recent years. The passing of the 2018 Farm Bill, which legalized hemp production, boosted the market, allowing companies to explore hemp as a primary ingredient. This ruling, dated May 15, 2024, is only the 15th such declaration by the agency since 2010.

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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. Post-market requirements cover activities such as registration and listing (21 C.F.R. By Adrienne R.

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Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. Revised in 2022, EU GMP Annex 1 currently represents the most thorough and up-to-date regulation on the manufacturing of sterile products.

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XTalks

NOVEMBER 23, 2023

This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing. The scandal led to stricter regulations on pesticide use and a push for organic farming methods.

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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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Drug Patent Watch

JANUARY 14, 2025

Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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XTalks

OCTOBER 4, 2021

Nestlé Cereals, a UK division of the international food giant, recently announced the launch of Cheerios Vanilla O’s, a low-sugar cereal that contains no artificial colors or flavors. Classified as non-HFSS (high in fat, salt or sugar) under new UK government regulations , the new cereal’s main ingredient is whole grains.

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Camargo

MAY 19, 2021

Established in 1990 with the passage of the Safe Medical Devices Act, the program creates an alternative pathway for market approval of medical devices that may help people with rare diseases or conditions. There are no apparent requirements for maintaining HUD prior to submission of an HDE or other device marketing application.

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XTalks

OCTOBER 13, 2023

Based in Traverse City, Michigan, NTFC is the first company to acquire a patent and bring to market a revolutionary culturing method that extracts sugar from fruit juice. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Sugar is ubiquitous.

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. This rule applies across all sectors and enshrines the fundamental principle allowing goods that originate in one market to be exported to the other without tax, duty or quota. Medical devices do not feature at all.

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Pharma Marketing Network

FEBRUARY 5, 2025

Table of Contents Sr# Headings 1 Understanding Pharmaceutical Market Access 2 Challenges in Pharmaceutical Market Access 3 Key Strategies for Market Access Success 4 Emerging Trends Shaping Market Access Understanding Pharmaceutical Market Access Bringing a new drug to market is only part of the battle.

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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.

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Pharma Marketing Network

JULY 13, 2023

. ● Security: Your website will likely contain sensitive information about your products and customers. Compliance: The pharmaceutical industry is heavily regulated. Make sure the company you choose is familiar with the applicable regulations and can help you ensure your website complies with them.

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Pharmaceutical Technology

FEBRUARY 8, 2023

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. Furthermore, due to smaller patient populations, rare disease trials are often smaller in size than other disease trials.

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Pharmaceutical Technology

APRIL 18, 2023

The companies help to design, develop and scale marketing strategies to effectively transition into a digitalised future. The document contains detailed information on the consent and preference management providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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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.

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Outsourcing Pharma

FEBRUARY 6, 2024

Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.

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