European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending.

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European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. The GAMP 5 Second Edition includes: Six completely new appendices.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

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The Checkup by Singlecare

JULY 20, 2024

Food and Drug Administration ( FDA ) as a weight loss medication. As of now, phentermine is not FDA-approved for ADHD, and the evidence of its effectiveness is scarce. Phentermine is an old psychotropic medication that is indicated by the FDA for the short-term treatment of weight loss,” she says. “It

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ISPE

FEBRUARY 13, 2023

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. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

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The Checkup by Singlecare

AUGUST 3, 2024

Latuda (lurasidone) is a brand-name prescription drug that’s approved by the Food and Drug Administration (FDA) to treat schizophrenia as well as bipolar depression associated with bipolar I disorder. As of the time this article was written, Latuda’s average price for 30, 40 milligram (mg) tablets is $1,859. How much does Latuda cost?

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The FDA Law Blog

APRIL 22, 2025

DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

This article will explore the advantages of using HCs, as well as several considerations for their effective use, including scientific methodology and regulatory guidance. FDA presentation. FDA Rare Diseases: Natural History Studies for Drug Development Guidance for Industry. Benefits of historical controls. Thompson, LA.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The original article can be found HERE. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond.

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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. Later work simply re-affirmed this finding.

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The FDA Law Blog

MARCH 9, 2023

We might conduct numerous interviews, look at thousands of documents, and travel to whatever locations are necessary. We prepare a report that we share with our client and make a recommendation to our client about whether to disclose the information to FDA. And, FDA still doesn’t.

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pharmaphorum

AUGUST 10, 2020

They must also comply with regulatory requirements, such as those defined by the FDA. Annotated CRFs are a key submission deliverable, a mandatory requirement of the FDA. In other words, “ each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets ” as stated by the FDA guidelines.

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pharmaphorum

AUGUST 3, 2020

They must also comply with regulatory requirements, such as those defined by the FDA. Annotated CRFs are a key submission deliverable, a mandatory requirement of the FDA. In other words, “ each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets ” as stated by the FDA guidelines.

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The FDA Law Blog

FEBRUARY 27, 2023

This error has appeared not just in articles and other news publications but in some court documents as well. In many cases, it appears DEA does not have the resources or infrastructure to maintain and produce the information to respond to FOIA requests as do other administrative agencies such as FDA.

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ISPE

FEBRUARY 16, 2023

The panellists included: Roberto Conocchia GMP Technical Lead European Medicines Agency (EMA) Rick Friedman Deputy Director, Office of Manufacturing Quality FDA/CDER Alan Moon Lead Senior GMDP Inspector MHRA The discussions were moderated by Mark Birse and Jean-Francois Duliere. This is a key concern for the FDA.

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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. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America.

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Viseven

SEPTEMBER 6, 2024

In our new article, you will learn more about data integrity in the pharmaceutical and life sciences industry and why maintaining it matters so much. Key Principles of Data Integrity In the 1990s, the FDA developed a list of principles of data integrity, which still serve as a framework for working with data and documenting it.

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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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Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

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DiversifyRx

NOVEMBER 24, 2023

If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. Document Everything Meticulous record-keeping is a fundamental aspect of DSCSA compliance.

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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.

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ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong. Sherwood Article of the Year Award.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. This article provides insight into process maps and data flows in the biopharma industry using the Reference Architecture Model Industry 4.0 The concepts introduced here will be topics for future articles.

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ISPE

SEPTEMBER 12, 2022

FDA/CBER/OMPT/OCBQ. And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. Director, Office of Pharmaceutical Quality Operations. 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor. Rick Friedman. Brooke Higgins. Robert Sausville.

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ISPE

JULY 6, 2023

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

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ISPE

SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 This was followed in September 2022 by the publication of the PIC/S’s identical Annex 1. m/s up to 0.54

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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). These media fill process simulations also serve to evaluate the aseptic technique used during operator interventions.

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The Checkup by Singlecare

SEPTEMBER 7, 2023

Some drugs in this class are FDA-approved to aid in weight loss and management. If looking for an alternative to Moujaro as a weight loss medication, there are GLP-1 receptor agonists with FDA approval for weight loss, such as Wegovy (semaglutide). Mounjaro (tirzepaptide), manufactured by Eli Lilly Inc.,

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The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

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ISPE

JANUARY 8, 2023

In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself.

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ISPE

JANUARY 11, 2023

1 , 2 This article explores the life-cycle approach to cleaning topical drugs and cosmetics with attention to the cleaning design phase and leveraging this information, including lab studies and pilot runs, for qualifying and monitoring the cleaning process. 1 US Food and Drug Administration.

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ISPE

MAY 10, 2023

This article discusses the main SPuMoNI accomplishments. Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Horacio Gonzalez-Velez, Ph.D.

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ISPE

SEPTEMBER 8, 2023

This article describes the goal of the initiative, characterizes the anticipated challenges to innovation, summarizes the industry’s need to innovate, and discusses regulatory initiatives that are currently in progress, including learnings from the recent pandemic. www.fda.gov/about-fda/oncology-center-excellence/project-orbis.

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Pharma Marketing Network

APRIL 30, 2021

The release in November of FDA’s final guidance on strategies to increase participation of underrepresented populations in trials ( “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” ) has given added impetus to these efforts.

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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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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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