The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Medical information about a patient. Other medical information.

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ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

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The FDA Law Blog

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. 25 In 2021 an estimated 25 million children under the age of one year did not receive basic vaccines, and the number of completely unvaccinated children increased by five million since 2019. 2019; 9:11409.

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pharmaphorum

JANUARY 27, 2023

She knows only too well how understanding the importance of patient centricity is crucial to the success of any modern life sciences company – but how has the landscape changed since 2019? “I Having the ability of these groups to be able to communicate directly with patients is tremendous.”

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The deprescribing.org Blog

APRIL 14, 2021

Providing good clinical care can be challenging as community pharmacists often don’t have access to useful resources, such as electronic health records. Communicating with prescribers, typically located offsite, can also have its challenges. Document, document, document. 2019 Jan 1;99(1):7-9. PMID: 30600973.

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ISPE

SEPTEMBER 28, 2023

billion in 2019 to $17.3 The sub-standard heights were discovered during the initial document review and site assessment. This issue was resolved using communication methods and reprogramming strategies from the TI and core and shell sides. billion in 2022.

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Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

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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. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.

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Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. Senator Chuck Grassley, along with three other senior GOP lawmakers, begins a two-year investigation of the 340B program. However, the U.S

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The Happy PharmD

SEPTEMBER 15, 2024

Based on the data, the average distress level among pharmacists has decreased compared to previous reports spanning from 2019 to 2022. in 2019 to 2.59. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. It has declined from 3.25

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published 15 November 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published 15 November 2021.

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PQA

JUNE 27, 2024

From 2018-2019, PQA convened a multistakeholder Specialty Pharmacy Turnaround Time Task Force to develop specifications for the measure concept, focused on establishing a standardized measure of the time between a specialty pharmacy receiving a new prescription for a specialty medication and the product being available for the patient (i.e.,

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ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Pharmaceutical Engineering (May/June 2019).

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. For DCTs, even a small virtual component can make the trial somewhat decentralised.

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Hospital Pharmacy Europe

JULY 3, 2024

4,5 The 2019 ENDPAPER study found that of 20 ED pharmacists working in 15 UK hospitals, there were two types of ED pharmacist: those working in a traditional pharmaceutical care role (similar to inpatient ward pharmacists) and those taking a more hands-on role assessing new patients on arrival at the ED.

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ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published 2019. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. Technical Report No.

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ISPE

SEPTEMBER 11, 2023

2 October 2019. Nature Communications 12, no. Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner.” 11 September 2019. 6 November 2019. 12 July 2019. 3 (2019):285. BioPharm International. Benefits of Prefabricated Modular/Podular BioPharma Facility Construction.”

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ISPE

JANUARY 8, 2023

Lecture Notes in Computer Science 11700 (2019) Springer, Cham. 8 April 2019. Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In: Samek, W., Montavon, A. Vedaldi, L. Hansen, and K. Müller (eds.). 12 November 2018.

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Viseven

DECEMBER 13, 2024

RPA employs software robots, or bots, to carry out tasks such as data entry and extraction, insurance claims processing, insurance verification, payroll calculations, document verification, employee onboarding, and many others. According to McKinsley, 55% of patients are more satisfied with virtual visits than face-to-face appointments.

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ISPE

MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. You may unsubscribe from these ISPE communications at any time. Juan Miguel García-Gómez, Ph.D. Chis, Ph.D.

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ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 ASHRAE Journal (2019): 38–54. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods” 2019. You may unsubscribe from these ISPE communications at any time. m/s up to 0.54 link] 5 Naughton, P.

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ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. Published November 2019. 22 June 2023. 3 July 2020.

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ISPE

MARCH 7, 2023

Published November 2019. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” 5 (2019): 517–521. [link] 4 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Press Release.

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ISPE

MARCH 9, 2023

To estimate the infiltrated door flows, design documentation can be used. Air communication between rooms was only allowed via a 0.5-inch 1 1 ISO Standard 14644-3. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods.” link] An equation is derived to predict the recovery time for a cleanroom that is challenged with 0.5-micron

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ISPE

MARCH 15, 2023

24 September 2019. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. Wiley (2019). New Biotechnology 49 (2019): 37–42. 1 July 2019.

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ISPE

JULY 10, 2023

In this constructive process, documentation regarding the decisions made are important to justify the model and explain-ability mechanism selection in an audit context.” April 2019. Prototyping strategies for early feedback and alignment reduce the acceptance risks further down the development process stream. Blumenthal, I.

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ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. Is the software MDSW according to MDCG 2019-11?

Health and Personal Care Stores 52

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ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. Is the software MDSW according to MDCG 2019-11?

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ISPE

JULY 5, 2023

Two of the most significant policy developments since 2014 have been the release of the Quality Considerations for Continuous Manufacturing draft guidance in 2019 and the International Council for Harmonisation (ICH) Q13 guidance on CM of drug substances and drug products in 2023. 3 (2019): 253–67. Lee, and S. doi:10.1016/j.tibtech.2018.08.008

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The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! May 22, 2019. May 16, 2019.

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Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. So why are so many clinical trials falling short of enrolment targets?

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ISPE

SEPTEMBER 10, 2023

Existing regulatory frameworks In the 1950s and 1960s, the WHO published documents outlining how countries should set up a regulatory framework to control pharmaceuticals and ensure the safety of their subjects. You may unsubscribe from these ISPE communications at any time. The proposals are consistent with WHO GRP. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf

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The Thyroid Pharmacist

JANUARY 20, 2023

The first case is outlined in a 2019 report by Roberto Vita and his research team, and published in Revista da Associação Médica Brasileira. Markomanolaki and published in a 2019 issue of Journal of Molecular Biochemistry. Published 2019 Jul 22. Published 2019 Dec 9. Published 2019 Aug 15. vs. 398 U/mL). [1]

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