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.

Pharmaceutical Manufacturing 119

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies 119

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.

Biosimilars 64

Biosimilars Documentation 64

Pharma in Brief

JANUARY 10, 2024

CIPO’s application fees – and “small entities” – are getting larger in 2024 On January 1, 2024, CIPO imposed the first substantial increases to its service fees since 2004 (see here ). Draft regulations are expected to be released for consultation in 2024. The fee increases apply to both patent and trademark applications.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 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 59

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?

Biosimilars 79

Biosimilars Labelling Documentation 79

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.

Documentation 52

Documentation Compounding 52

GMPSOP

DECEMBER 28, 2022

Environmental monitoring is a documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas. Additional documents included each month. Additional documents included each month. Table of Contents What is meant by environmental monitoring? Checkout sample preview s.

Documentation 52

Documentation Vaccines 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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.

Immunity 105

Immunity Immunization Dosage Documentation 105

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.

Documentation 52

Documentation Labelling Immunity Immunization 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 61

Labelling Documentation Hospitals 61

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 97

Dosage Immunity Immunization Documentation 97

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 104

Health and Personal Care Stores Immunity Immunization Documentation 104

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 Hospitals Dosage Drug Pricing 97