FDA Law Blog

NOVEMBER 22, 2022

coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S.

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Contamination Production Manufacturing Packaging 52

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

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Packaging Packaging Containment Production 40

XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. This phase-out comes after an FDA post-market scientific review and analysis from studies found bio-persistence of the grease-proofing substances.

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Packaging Packaging Contamination Containment 98

XTalks

FEBRUARY 5, 2021

There are a variety of materials that are used for food packaging, and they serve some very important functions in the food industry. Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass.

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Packaging Packaging Contamination Containment 64

Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. The amendments contemplate labelling flexibilities for special containers. Manufacturing Controls. On-site Evaluations.

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Regulation Drugs Manufacturing Production 98

XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

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Packaging Packaging Containment Contamination 52

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.

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Sales Insulin FDA Approval Drugs 52

Roots Analysis

SEPTEMBER 29, 2023

A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation. A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation.

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Contamination Containment Biobanking Packaging 40

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments. Plastic accounts for 20 to 25 percent of total waste generated by healthcare facilities.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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Drug Delivery Contamination Drugs Production 40

Pharmaceutical Technology

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.

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Drugs Packaging Packaging Contamination 130

Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. KB: Some formulations contain low concentrations of the active ingredient. Solid state reactions occur much more slowly than liquid interactions. A great example is aspirin. Why are bulking agents used in lyophilization?

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Production Contamination Development Manufacturing 130

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. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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Contamination Manufacturing Containment Production 130

FDA Law Blog

DECEMBER 14, 2023

They observed that unregulated cannabis products have been found to contain fentanyl, high levels of heavy metals, contaminants, and even high delta-9 tetrahydrocannabinol (“THC”) concentrations.

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Regulation Production Contamination Drugs 59

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. And stimulus packages continue.

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Vaccination Vaccine Antibody Life Science 92