ISPE

JANUARY 10, 2023

Tue, 01/10/2023 - 12:15. iSpeak Blog. 10 January 2023. The Robotic Session during the 2023 ISPE Aseptic Conference in Bethesda, MA on 6-7 March has been established for several years. We both agree that the next aseptic conference in 2023 will be full of interesting topics. 2023 ISPE Aseptic Conference.

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The 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. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

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The FDA Law Blog

DECEMBER 8, 2022

1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023, sesame. All packaged foods served or sold on transportation carriers (e.g., labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and.

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Digital Pharmacist

DECEMBER 22, 2023

In this blog, we’ll explore the pharmacy trends shaping the industry in the coming year, providing insights to help your business thrive in the face of these transformations. Recognizing and addressing these changing dynamics is crucial as we step into 2024.

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The FDA Law Blog

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). This all sounds complicated, I know.

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ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities.

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ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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The 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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ISPE

MARCH 14, 2023

The survey was distributed via an email communications to ISPE members, a blog on ISPE’s website, and LinkedIn postings. In this two-part blog series, we first spotlight a summary of the survey findings of the current status for handling single-use items once they have completed their mission.

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The FDA Law Blog

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. 355(j)(2)(A)(v). .

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Roots Analysis

OCTOBER 5, 2023

Presently, polymers are employed in various fields, including agricultural, aircraft, automotive, consumer science, medicine, packaging, and sports. As per the base case forecast scenario, medical polymers market size is estimated to grow at a CAGR of ~9%, forecast period during 2023 – 2035.

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The FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Devices can have both a UPC code and a UDI on their label and package.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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ISPE

MARCH 9, 2023

Date: Thursday, 23 March 2023 Time: 0900 – 1200 ET | 1400-1700 CET Price: Free for ISPE members This event will be an interactive virtual event leveraging the Remo online event platform. There will be a kick off the event with an overview of the ISPE Communities of Practice (CoPs).

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ISPE

JANUARY 24, 2023

We revisit a favorite topic, sustainability—and will be updating our coverage of this topic with the upcoming March-April 2023 issue of Pharmaceutical Engineering.

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ISPE

FEBRUARY 14, 2023

During paper-based inspection events, a CQV package is requested and a printed report with a physical binder are brought in to support the request. For digital CQV systems, protocols, binders, and sometimes the reports, are merged into single digital packages. Is the user access roster reviewed on a periodic basis?

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ISPE

NOVEMBER 29, 2022

iSpeak Blog. The 2023 ISPE Aseptic Conference will devote one entire day to case studies related to aseptic manufacturing projects. Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers. Aseptic Manufacturing Case Studies Preview. Trudy Patterson.

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The FDA Law Blog

NOVEMBER 7, 2022

Kirschenbaum — On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. The requirement to use a JW modifier for discarded amounts beginning on January 1, 2023 remains in place.

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Roots Analysis

OCTOBER 30, 2023

Some of the recent developments in the next generation RNA therapeutics and vaccines domain include: In February 2023, Tevard Biosciences entered into a research and development agreement with Vertex Pharmaceuticals for the development of novel tRNA therapeutics, intended for the treatment of Duchenne Muscular Dystrophy.

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The FDA Law Blog

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). To be considered by FDA, comments must be submitted by January 3, 2023. In addition, FDA will assess a penalty of 6 percent per year on any invoice delinquent for more than 90 days.

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The FDA Law Blog

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

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ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. 7 June 2023. iSpeak blog. McQueen Nina S. Advanced Manufacturing.” link] 2 Lee, K.

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The FDA Law Blog

DECEMBER 14, 2023

The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).

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