Comments on the poll question "Funding FDA Inspections"
Article
Your comments to the poll question: The proposed Food and Drug Administration Globalization Act of 2008 recommends imposing a fee for inspections to fund the cost of FDA inspections (both domestic and foreign inspections). If such a measure is adopted, how should the fee be assessed?
Your comments
"Regarding inspection fees, one approach for establishing fees would be to assess the actual cost or the average cost for doing the inspections after let’s say 100 inspections at various size manufacturing plants. The FDA could then establish, based on the size of the manufacturing facility, a fixed fee. The larger manufacturing facilities might have a larger fee. Many local governments set their fees based upon a historical average of what it costs to perform the task. The goal is that the local municipality is able to recover their out-of-pocket costs and not make any profit from the fees."
The question
The proposed Food and Drug Administration Globalization Act of 2008 recommends imposing a fee for inspections to fund the cost of FDA inspections (both domestic and foreign inspections). If such a measure is adopted, how should the fee be assessed?
1. On a facility basis, based on the size of the manufacturing facility. 2. On a company basis, based on company revenues. 3. On a company basis, based on the number of manufacturing facilities operated by the company. 4. A flat fee for all companies with pharmaceutical manufacturing facilities.
Click here to submit a comment. Go to the poll archive to see past questions and results.
Comments on the poll question "Funding FDA Inspections"
Your comments to the poll question: The proposed Food and Drug Administration Globalization Act of 2008 recommends imposing a fee for inspections to fund the cost of FDA inspections (both domestic and foreign inspections). If such a measure is adopted, how should the fee be assessed?
Your comments
The question
The proposed Food and Drug Administration Globalization Act of 2008 recommends imposing a fee for inspections to fund the cost of FDA inspections (both domestic and foreign inspections). If such a measure is adopted, how should the fee be assessed?
1. On a facility basis, based on the size of the manufacturing facility.
2. On a company basis, based on company revenues.
3. On a company basis, based on the number of manufacturing facilities operated by the company.
4. A flat fee for all companies with pharmaceutical manufacturing facilities.
Click here to submit a comment. Go to the poll archive to see past questions and results.
Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried
Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.
Transformations in Drug Development for Cell and Gene Therapies
As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
From Thema4 to TH5: The Evolution of Fedegari’s Autoclaves
An article describing the technological advancement from one process controller to the new one.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Strategies for Mitigating Nitrosamine Risk
Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.
Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried
Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.
Transformations in Drug Development for Cell and Gene Therapies
As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
From Thema4 to TH5: The Evolution of Fedegari’s Autoclaves
An article describing the technological advancement from one process controller to the new one.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Strategies for Mitigating Nitrosamine Risk
Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.