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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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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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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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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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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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.

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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 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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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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STAT

OCTOBER 16, 2023

The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertising databases, leaked documents, and research reports.

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The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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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.

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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.

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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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The FDA Law Blog

APRIL 6, 2025

Gaulkin & Esther Petrikovsky Last week, the Supreme Court issued a unanimous decision in FDA v. 2, 2025) that affirms FDAs denial of authorization to market flavored vape products. Following several years of delayed enforcement, FDA began reviewing a first wave of applications. Wages & White Lion Investments, LLC , No.

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European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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