European Pharmaceutical Review

JUNE 24, 2022

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. Nitrosamine Imp -Q&A-Mar-22.pdf. Accessed on 02 April 2022.

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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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

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. During the COVID-19 pandemic, the US FDA issued guidelines for remote evaluations of drug manufacturing and bioresearch facilities. This is achieved by off-the-shelf technology.

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Communication Documentation FDA 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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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.

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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. This Class II medical device is FDA-cleared and meant to target all kinds of pain. References [1] Nanan R, Wall JR.

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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.

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Documentation FDA 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.,

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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? October 2004. m/s up to 0.54

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Documentation FDA Packaging Communication 52

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

SEPTEMBER 11, 2023

September 2004. September 2004. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. 3 (2022):593–607.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. EU human tissues and cells directive 2004/23/EC; 7. EU human tissues and cells directive 2004/23/EC; 7. FDA CFR Title 21 Parts 211, 600, and 1271; 8. ,

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Vaccines Compounding Documentation FDA 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.

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ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). A formal change control system under the company’s pharmaceutical quality system (PQS) is required to evaluate all raw material changes, with established procedures for identification, documentation, review, and approval.

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Documentation FDA Packaging Communication 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.

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