pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs. 4 integrins, which play a key role in MS pathology.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

The Checkup by Singlecare

DECEMBER 1, 2023

That is 170% of the daily value (DV) recommended by the US Food and Drug Administration (FDA). Cereal To reduce vitamin D deficiency in America, the FDA now allows more vitamin D to be added to breakfast cereals. The FDA advises adults to have no more than three servings of canned, light tuna per week.

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Labelling Mayo Clinic FDA Immunization 93

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JANUARY 11, 2023

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. link] 4 Pluta, P.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? m/s up to 0.54 At what velocity?

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Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. Published August 2009. www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program 9 US Food and Drug Administration Center for Drug Evaluation and Research. Published January 2023.

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FDA Documentation Dosage Communication 52

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. 2010;20(7):755-761. doi:10.1089/thy.2010.1636. Empting LD. doi: 10.1177/0748233709348393.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

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FDA Documentation Communication 52

ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Documentation FDA Hospitals Dosage 97

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2009-0041.

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Documentation Dosage FDA Communication 98