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. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Pharmaceutical Technology

MAY 17, 2023

Marketing Packages Taking part in the Excellence Awards offer your company many benefits including being able to tell the market, new and prospective clients about your achievement. For full details on the benefits, the scale of our audience and the marketing packages on offer please download the RESEARCH GUIDE.

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European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. The PFAS regulatory challenge As a result, in the EU, a joint PFAS Restriction Proposal under REACH was submitted in 2023, aiming for a full ban on all PFAS by 2028/2030.

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ISPE

JANUARY 10, 2023

Tue, 01/10/2023 - 12:15. 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. This can be found seven times in the entire document. We both agree that the next aseptic conference in 2023 will be full of interesting topics.

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European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

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European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. References European Commission, (26 April 2023). European Commission, (28 June 2023) “Access to essential services: key challenges for the most vulnerable – report” Euractiv (26 September 2023). Euractiv (6 October 2023).

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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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Pharmaceutical Technology

APRIL 14, 2023

Although the organisation previously shared a draft version of the report in February, the revised document features new details on the drugs’ potential fair pricing. Obeticholic acid will be in the spotlight when an approval package for its use in NASH will be discussed at a Gastrointestinal Drugs Advisory Committee meeting on May 19.

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Packaging Documentation 52

ISPE

MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. Additional required information beyond ICH guidelines, or non-value-added documents (e.g.,

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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.

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ISPE

MAY 11, 2023

™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Methodology to Define a Pharma 4.0™ to Industry 4.0

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The Checkup by Singlecare

FEBRUARY 23, 2024

And as of December 2023, BCBS covers nearly 118 million people , which is about 1 in 3 Americans. per package, which is equivalent to about $16,188 per year. How to check whether your BCBS plan covers Wegovy The first step in determining if Wegovy is covered by your plan is to check your plan documents.

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Brown Megan E.

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ISPE

JULY 1, 2023

Documentation has experienced the same incredible advancements and that has significant impacts on industries that are dependent on it, such as the life sciences industry, consumer packaged goods manufacturers, and businesses involved in other highly regulated fields.

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Brown Megan E. McMahon Timothy J.N.

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European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2. 2023; 11 (17), 6510-6522. 2023; 33:5. 2023; 33(1): 24. Cited 2024August].

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Hospital Pharmacy Europe

MAY 22, 2024

The UK Health Security Agency’s ‘Start smart then focus’ AMS toolkit – first published in 2011 and most recently updated in September 2023 – makes evidence-based recommendations on effective AMS practices in hospitals, including appropriate management of penicillin allergy labels.

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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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ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. A draft of these updates should be provided with the validation documentation and implemented upon successful execution.

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PQA

JUNE 27, 2024

Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure. Barriers to Optimizing TAT Prior authorizations are often responsible for longer TAT, with many participants expressing the burden of rigorous documentation required by payers.

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Hospital Pharmacy Europe

JULY 3, 2024

In 2023, the Royal College of Emergency Medicine and the UK Clinical Pharmacy Association recommended all EDs have a dedicated pharmacist and, as of 2024, approximately 77 of 170 UK EDs (45%) have a clinical pharmacy service. Recognition is about developing concerns or suspicions as to whether a patient has been maltreated.

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Hospitals Communication Patient Care Packaging 52

ISPE

MARCH 15, 2023

Environmental Sustainability in Biopharmaceutical Facility Design Trudy Patterson Wed, 03/15/2023 - 09:13 Online Exclusives March / April 2023 Environmental Sustainability in Biopharmaceutical Facility Design William G. Table 1: Facility environmental sustainability tools and example values. 7 An integrative (vs. 7 An integrative (vs.

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ISPE

SEPTEMBER 11, 2023

Trudy Patterson Mon, 09/11/2023 - 06:10 Features September / October 2023 Air Speed Qualification: At Working Position or Working Level? 3 Lastly, the WHO published the new guideline under their framework in January 2023 as Annex 2. x, a free and open-source computational fluid dynamics (CFD) software package.

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Documentation FDA Packaging Communication 52

ISPE

MARCH 7, 2023

The facility would need to be designed, constructed, commissioned, and validated for occupancy and use by the summer of 2023, when projected growth would test the capacity of existing facilities. Going Live Following design and permitting, project construction began October 2021 and is now nearing completion in spring 2023 (see Figure 6).

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PharmTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. Analytical Validation (ICH, 2023).

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ISPE

MARCH 7, 2023

Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Trudy Patterson Tue, 03/07/2023 - 09:14 Features March / April 2023 Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Guy Wingate, PhD Ylva Ek Patricia M. that apply to the scope of activities undertaken by their organization.

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European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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The People's Pharmacy

MAY 8, 2023

” Its investigation into foreign FDA inspections is shocking (April 19, 2023): “A ProPublica analysis of FDA inspection data as of April shows that the agency’s inspections of overseas drug manufacturers, located mostly in India and China, has dropped precipitously even as the number of manufacturers has remained relatively steady.

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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. Accessed 14 April 2023. Updated January 2023. McQueen Nina S.

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The FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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ISPE

SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. Accessed 14 June 2023. Accessed 14 June 2023. Published 2021.

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ISPE

JULY 6, 2023

Pharma Investment Trend Report: What We’re Watching in 2023.” Published 13 January 2023. Updated 10 January 2023. addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation. Adopted January 2023. Zydney, and J.

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PharmaVoice

JUNE 11, 2025

The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. Plus, the package would require all rebates or discounts received by PBMs to be passed on to a Medicare Part D plan sponsor, according to a recent brief by Mintz.

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