The FDA Law Blog

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

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European Pharmaceutical Review

JUNE 24, 2022

Following initial consultations in 2021, we expect the publication of the proposal for changes to the EU’s pharmaceutical legislation and potential adoption by the European Commission (EC) by December 2022. It is too early to say because we have not seen the whole package of measures yet. London: Dolon Ltd; 2021. References.

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pharmaphorum

NOVEMBER 29, 2021

From clear communication with an unsettled, dispersed workforce to maintaining positive energy and managing people’s working hours, the need for open, inclusive and empathetic leadership has never been more important. . iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., gym membership).

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ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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pharmaphorum

MARCH 16, 2022

Future onsite-and-online conferences present significant decision-making challenges to the pharmaceutical industry, amply demonstrated by the sponsored symposia options, shown in Figure 5, which were available at the 2021 EAACI hybrid conference. Figure 5 Sponsored symposia options at the EAACI hybrid congress 2021.

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Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. One of the most common use cases is Internet of Things (IoT) sensors placed on containers and packaging to track humidity and temperature in real-time. This made the procurement process more expensive, time-consuming, and ridden with errors.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. Uniquely, a group of eight independent companies and users of robotic workcells, aggregated their data from 2018- 2021, to assess the performance of innovative aseptic filling technology and help drive modern regulatory standards. 1] BioNews. Hemophilia News Today.

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IDStewardship

NOVEMBER 29, 2023

In 2021 I enrolled in a Master’s for Microbiology and cell science at the University of Florida and I am expecting to complete it in December of 2024. Not being afraid to communicate with people has been important to my success. I think that is where I do my best work I. I have found a lot of my guests through social media.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). 1 (2021):48. 6540 (2021):341–42. Nature Communications 12, no.

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ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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ISPE

MARCH 7, 2023

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Journal of Pharmaceutical Sciences (2021). Common Technical Document [CTD] sections). Sugrue-Richards, and G.

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ISPE

MARCH 6, 2023

Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021. Yet if we consider these 74 companies to be representative of the entire biotechnology and pharmaceutical industry, the carbon intensity has increased by over 40% since 2015, with a marked increase over the last 2 years (2020 and 2021).

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ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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ISPE

MARCH 29, 2023

Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. 5 (2021): 60–62. Published 3 September 2021. Recorded 25 August 2021. Updated May 2021.

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ISPE

OCTOBER 27, 2022

16 (20 September 2021): 9026–41. As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. You may unsubscribe from these ISPE communications at any time. Pharmaceutics 14, no. 2 (February 2022): 260.

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ISPE

MARCH 7, 2023

10 May 2021. Representatives from R&D, manufacturing and supply, and commercial should all be included at the top-level forum, along with the main functions needed for delivery such as the sustainability group, engineering, procurement, legal, and corporate communications. October 2021. Gerber, and K. April 2016. March 2004.

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ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 14–25 (November–December 2021). HowToRobot.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. 5 (September/October 2021). 2021.09.046 2021. Published 2008. Guidance for Industry.

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ISPE

OCTOBER 27, 2022

Published 17 May 2021. 53 (2021): doi:10.1038/s41392-021-00487-6. Different engineering disciplines, such as architectural and process piping, may use different software packages, which can then be combined into a single coordinated model. Published 21 September 2021. Accessed 11 August 2021. Viral Vector Modality.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. Free Whitepaper. By Datwyler.

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Pharmaceutical Technology

APRIL 21, 2023

Nevertheless, Narcan represents a life-saving treatment option that is free of prescription barriers and will be key in managing a drug epidemic that resulted in the deaths of more than 106,000 people in America in 2021. “We 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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ISPE

SEPTEMBER 10, 2023

In these countries, a secondary packaging site change or an active pharmaceutical ingredient (API) manufacturing site addition triggers a new submission equivalent to that required for approval of a generic drug or a line extension, whereas these site changes may be filed as a notification in the US and EU. Published 2021. Edwards, K.

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity. Catalent Inc has been tasked with the solid dose manufacturing for the drug.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. The question is whether rising inflation levels and major global events will allow for development and innovation.

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Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. billion in 2021, which is expected to reach $15.77 Recent analysis valued the market [i] at USD 8.5

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Please check your email to download the Webinar.

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Pharmaceutical Technology

DECEMBER 15, 2022

Kenilworth, NJ, US) is investing $500 million in its Singapore facilities, including setting up a secondary packaging facility and building an inhaler production plant. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Additionally, Merck & Co. Free Report.

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Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164).

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Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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Pharmaceutical Technology

JANUARY 20, 2023

In a 2021 GlobalData poll 3 , environmental issues were viewed as the most important area that pharma needs to address, according to 43% of respondents. While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights.

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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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