Pharmaceutical Technology

MARCH 29, 2023

With the new version of EU GMP Annex 1 coming into effect on 25 August this year, big changes to the way the pharmaceutical industry approaches container closure integrity testing (CCIT) are in motion. In addition, 100% testing is now required for fusion-sealed containers such as ampoules and IV bags.

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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. Manufacturing Controls. The amendments contemplate labelling flexibilities for special containers. Risk Management Plan (RMP).

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Pharmaceutical Technology

MARCH 10, 2023

The list also includes manufacturers and suppliers of biological safety cabinets, clean benches, nanotechnology enclosures, drying chambers, vacuum pumps, filters, remote blowers and exhausters, loading and unloading systems as well as controlling and monitoring systems.

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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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XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . Respondents cited packaging as the top area brands should focus on if they want to increase purchase intent.

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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. In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects.

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FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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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.

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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. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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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. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

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FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

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Camargo

NOVEMBER 15, 2021

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.”. The guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

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Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Thermo Fisher states on its website that “Given the ongoing conflict, we have paused sales and manufacturing operations in Russia and Belarus.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

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FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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XTalks

JULY 27, 2022

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. He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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FDA Law Blog

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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FDA Law Blog

NOVEMBER 16, 2021

Kirschenbaum — While most of the Congressional focus on drug pricing has centered on the reconciliation bill currently being hammered out in the House and Senate, the Infrastructure Investment and Jobs Act (the “Act”), which was signed by President Biden yesterday, contains two provisions relating to drug payment and discounting.

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

DECEMBER 14, 2023

Conceding that they may disagree whether legalization of recreational cannabis or cannabis use is a “net positive,” the governors agreed that the cannabis industry is permanent, that states have implemented “strong regulations,” and supporting the state regulated cannabis marketplace “is essential for the safety of the American people.”

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FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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XTalks

AUGUST 15, 2023

In a nation where the majority of store-bought food contain incomprehensible ingredients and employ labeling tactics designed to confuse consumers, understanding the nature of our snacks and meals can often prove difficult. Preservatives and additives serve as routine ingredients for manufacturers, extending the shelf-life of food products.

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XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

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XTalks

FEBRUARY 13, 2024

Starbucks Refreshers: Fruitful Imagery without the Fruit Starbucks faced criticism and legal action with its Refreshers lineup, accused of misleading consumers by suggesting that the drinks contained real fruit corresponding to their names, when in fact, they did not.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. The courts also had a busy year in 2021. b) Continued changes to the PMPRB.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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XTalks

JUNE 27, 2023

To meet consumer demand, food manufacturers may need to seek alternative suppliers; however, food manufacturers must remain vigilant against food fraud, especially when engaging with new suppliers who may not have undergone proper vetting.

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Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

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XTalks

NOVEMBER 9, 2022

Related: Misleading Food Labeling a Cause for Concern Among Consumers and Food Manufacturers. However, ultra-processed foods contain more artificial ingredients than those that just have added salt, sugar or oil. They usually have very few whole ingredients and contain flavorings, colorings or other additives.

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Pfizer

APRIL 26, 2023

We’ve pioneered solutions to distribution and storage requirements In the last few months alone, Pfizer has developed cutting-edge packaging and storage solutions to meet the needs of the varied locations that will be distributing the vaccine - whether they are in a major cites or rural towns. In the U.S.,

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FDA Law Blog

NOVEMBER 14, 2022

The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.

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XTalks

MAY 19, 2022

According to the company, products were manufactured by a third party and subsequently distributed across North America. Rather, they are specific packages of the “Gummies” variety of these products. The products, which were recalled in the US, include Starburst, Skittles and Life Savers gummies.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Few contract development and manufacturing organizations (CDMOs) are able to provide radiolabeling services as part of a fully integrated pharmaceutical development program. We recruit healthy volunteers who are made aware of the demands placed by human ADME research at our purpose-built, self-contained study ward and laboratory.

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Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is your advice for approaching the regulatory strategy?

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pharmaphorum

JANUARY 30, 2023

The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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