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

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. ,

Vaccines 97

Vaccines Compounding Documentation FDA 97

Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US. This suspicion was confirmed in a 2004 analysis by researchers from Oxford.

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Documentation Communication Patient Care Hospitals 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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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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.

FDA 52

FDA Documentation Compounding 52

ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. Please note that views expressed by the panelists are not necessarily representative of the position of the FDA, and that questions and responses are lightly edited for clarity. How will the FDA use Annex 1 in its final version?

FDA 52

FDA Vaccines Documentation 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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

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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Documentation Labelling FDA 52

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

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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.

Documentation 52

Documentation FDA Packaging Communication 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? October 2004. m/s up to 0.54

Documentation 52

Documentation FDA Packaging Communication 52

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.

Dosage 98

Dosage FDA Immunization Documentation 98

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.

Communication 52

Communication Documentation FDA 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

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

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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