ISPE

FEBRUARY 13, 2023

Bob came to ISPE in 2004, furthering an already distinguished career in the pharmaceutical industry and as a regulator. Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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pharmaphorum

DECEMBER 28, 2022

This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

Documentation 52

Documentation Communication 52

ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Documentation 98

Documentation FDA 98

pharmaphorum

OCTOBER 30, 2022

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA 52

FDA Documentation Labelling Immunization 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

Documentation 97

Documentation FDA Hospitals Dosage 97

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.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Hospital Pharmacy Europe

JANUARY 4, 2023

The study included data on 79,658 women in the NHS, 93,932 in the NHS II and 31,440 men in the HPFS (2004-2016), without prior stroke or CHD. During >2 million person-years of follow-up, 3603 incident stroke and 8620 incident CHD cases were documented.

Medical Schools 52

Medical Schools Documentation Hospitals 52

Hospital Pharmacy Europe

JUNE 8, 2023

This suspicion was confirmed in a 2004 analysis by researchers from Oxford. They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

Documentation 52

Documentation Communication Patient Care Hospitals 52

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

Labelling 98

Labelling Documentation 98

Pharmaceutical Technology

FEBRUARY 24, 2023

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs.

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Documentation 64

ISPE

NOVEMBER 30, 2022

Nik helped to create ISPE Guidance Documents and training materials including a Critical Utility GMP Compliance Training Course based off of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It. Nik has been a member of ISPE since 2004.

Documentation 52

Documentation Dosage Compounding 52

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

European Pharmaceutical Review

JUNE 24, 2022

FDA briefing documents that address these reformulation strategies should include a description of the formulation design strategy that is employed to minimise the formation of NDSRIs in the drug product, including supporting manufacturing information and, at a minimum, three months of accelerated stability data demonstrating control of NDSRI.

FDA 52

FDA Documentation Compounding 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). Published September 2004. link] 3 US Food and Drug Administration. Guidance for Industry. link] 5 Polzer, A.,

Documentation 52

Documentation Labelling FDA 52

European Pharmaceutical Review

JULY 20, 2023

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].

Labelling 75

Labelling Documentation Hospitals 75

ISPE

JULY 10, 2023

Since 2004, Roche/Genentech has been implementing carbon dioxide reduction measures that have led to a 59% absolute reduction in greenhouse gas (GHG) emissions from our own operations and purchased energy (Scope 1 and 2). September 2004. Now the implementation can focus on risk controls. 5 US Food and Drug Administration.

Documentation 52

Documentation FDA 52

Hospital Pharmacy Europe

JULY 3, 2024

ED pharmacy services were surveyed for the first time in 2004. The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation. So, UK ED pharmacy practice was born.

Hospitals 52

Hospitals Communication Patient Care Packaging 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 October 2004. But it is likely that interpretations in practice refer to footnote 5 from FDA Aseptic Guidance 2004: 7 “A velocity of 0.45 meters per second, plus or minus 20%, which is from 0.36 m/s up to 0.54

Documentation 52

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. March 2004. link] 15 Begley, A.

Health and Personal Care Stores 52

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 15, 2023

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. March 2004. link] 28 World Resources Institute and World Business Council for Sustainable Development.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

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.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 26, 2022

EU human tissues and cells directive 2004/23/EC; 7. 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 March 2004. Published October 2004. FDA CFR Title 21 Parts 211, 600, and 1271; 8. ,

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. For remote testing, several procedural changes have been made to accommodate the capturing of document approval. This is achieved by off-the-shelf technology. 16 O’Flaherty, B.,

Communication 52

Communication Documentation FDA 52

The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. What is extraordinary about this scandal is that the FDA inspected one of the Ranbaxy facilities in 2004. We know from investigating the FDA’s approval process ourselves that the honor system does not work.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The Thyroid Pharmacist

MARCH 31, 2023

A study in 2004 found an association between the presence of a mood or anxiety disorder, and the presence of anti-TPO antibodies. [1] Published 2004 Aug 18. She had already seen some major improvements with her Hashimoto’s through the use of thyroid medications as well as eating a Paleo diet , yet her anxiety persisted.

Immunization 105

Immunization Documentation Dosage 105

The Thyroid Pharmacist

JULY 14, 2023

Fortunately, my colleague Dr. Kirk Gair from West Covina, CA, who is also a Hashimoto’s patient, has used cold lasers in his clinic since 2004 and has developed protocols that combine LLLT with chiropractic modalities. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography.

Dosage 98

Dosage FDA Immunization Documentation 98

ISPE

SEPTEMBER 11, 2023

September 2004. September 2004. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf 66 a b DitaExchange.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

SEPTEMBER 8, 2023

Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER Annex 1 is aligned and in harmony with the FDA’s guidance for aseptic processing from 2004. How will the FDA use Annex 1 in its final version? There is no raw data to support the claims made in those reports.

FDA 52

FDA Vaccines Documentation 52

The Thyroid Pharmacist

JUNE 14, 2023

A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! Published 2004 Aug 18. Like women, men can develop hormonal changes after the birth of a child, which can be linked to postpartum depression. [14] His wife had Hashimoto’s.) BMC Psychiatry.

Health and Personal Care Stores 111

Health and Personal Care Stores Immunization Documentation Compounding 111

The FDA Law Blog

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

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