The FDA Law Blog

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

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FDA Packaging Documentation 62

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. It supports the analysis of Industry 4.0 to Industry 4.0

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DiversifyRx

JULY 11, 2024

To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request. The 3Ts can be in any format (paper, pdf, email), provided the required contents are all present.

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Independent Pharmacies FDA Documentation CPhT 52

ISPE

JANUARY 10, 2023

This can be found seven times in the entire document. aseptic processing line, filling zone, stopper bowl, open primary packaging or for making aseptic connections under the protection of first air).". Another focus of the project presentation is paperless production.

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Packaging Documentation 96

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. In July, approximately a third of companies had paused a trial in the country.

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Packaging Documentation 52

PharmaShots

JUNE 1, 2023

We presented our first results this year at ESMO and ESMO-IO. These new results reinforce our differentiating data package for PDC*lung01. The target population of PDC*lung is initially limited to HLA-A2+ patients, as the PDC*line HLA-A2 cell line is used to load and present the selected antigens.

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Immunization Vaccines Health and Personal Care Stores Labelling 40

DiversifyRx

APRIL 27, 2023

You could copy those or create a simple MS Word document to hand out to each prescriber. #4 When you have to say “no,” take the time to explain why and present other suitable alternatives. Give them a guide for how popular compounds are prescribed, from starting doses and titrations to how to do weight-based dosing.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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Documentation Dosage Packaging Communication 52

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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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

Such changes can include increasing batch sizes, adding manufacturing facilities, creating new product presentations, and updating analytical methods. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Common Technical Document [CTD] sections).

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Documentation FDA Communication Packaging 52

Hospital Pharmacy Europe

JULY 3, 2024

Those with life-threatening illnesses often arrive by ambulance, whereas other patients might self-present with relatively minor, self-limiting complaints. The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation.

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Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. 2011 Consecutive case series (n=12) Patients included if toxicology service was present to participate in management. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Page et al.,

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Packaging Documentation 52

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. This is followed by DP manufacturing, where the DS is formulated with excipients.

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Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 x, a free and open-source computational fluid dynamics (CFD) software package. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 m/s up to 0.54

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Documentation FDA Packaging Communication 52

ISPE

MARCH 7, 2023

Company standards for various aspects of environmental sustainability should be defined in technical documents and procedures that complement Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc. 16 8 Medicines Agency.

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ISPE

JULY 6, 2023

Operational Flexibility/Capacity Decentralized manufacturing Presently, portable end-to-end CM plants are not a widespread reality, but have been proven possible. addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation.

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HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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 March 2020.

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Pharmaceutical Technology

NOVEMBER 28, 2022

A growing ageing population presents many challenges for health services globally that are already buckling under the strain of recovering from Covid-19, and wearable tech is providing a solution. We source as much of the materials as we possibly can locally, even packaging,” he notes. We have the skills. Printing is done in Glasgow.

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