Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Documentation 105

Documentation Drug Development Communication 105

Putting Patients First Blog

FEBRUARY 5, 2024

The NHC strives to share relevant policy work such as comment letters, working documents on policy positions, and white papers with its members well ahead of deadlines. The NHC also provides access to deep policy resources and expertise on a broad range of complex issues that impact all people with chronic conditions.

Documentation 59

Documentation Communication 59

Pharmaceutical Technology

JANUARY 20, 2023

To learn more about the ways that the 3MTM Harvest RC Chromatographic Clarifier can increase efficiencies in the production of mAb therapies, download this specially commissioned white paper.

Documentation 52

Documentation Communication 52

European Pharmaceutical Review

DECEMBER 23, 2022

To enable this, the design documentation, whitepaper and testing results have been made available open source to all, 6 with the hope that we will see this technology become the standard for buffer preparation as we look to create further efficiencies in the future. . References. cited 2022Nov] Available from: [link].

Documentation 98

Documentation 98

FDA Law Blog: Biosimilars

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. See , e.g. , ACLA White Paper on LDTs here. Rulemaking avoids the twin problems of dependency on action by Congress and the legal weakness of imposing substantive legal requirements through guidance.

Documentation 54

Documentation 54

Putting Patients First Blog

APRIL 6, 2023

In 2021, the CDC documented a sharp rise in HAIs, which prior to the pandemic had been steadily decreasing. In March of 2022, APIC published a call-to-action white paper , exploring the lessons learned by IPs during COVID and highlighting the actions necessary at the facility level and the U.S.

Nursing Homes 52

Nursing Homes Long-Term Care Facilities Hospitals Documentation 52

pharmaphorum

FEBRUARY 24, 2022

Unlike many of its predecessors, then, this document is not merely an exercise in raising awareness. BIVDA really hope that the white paper will help inform UK policy makers and give them areas to focus on which we, as a coalition, see as critical to start moving this issue forward.”. Clear objectives.

Documentation 52

Documentation Vaccines 52

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For more information on this, please download our white paper. For more information, please download our white paper.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Pulses

MAY 25, 2023

While I was able to keep all documentation on Canvas, I had to constantly check submissions, which took a significant amount of time. 2021-22 American Association of Colleges of Pharmacy Competency-Based Education Joint Task Force White Paper. References Competency-based education task force. Posted August 8, 2022.

Documentation 98

Documentation 98

Express Pharma

OCTOBER 19, 2024

Furthermore, initiatives aimed to enhance knowledge sharing through publishing white papers, guidelines and research reports as well as providing network opportunities to foster dialogue between the industry and regulators assure that the industry remains informed. References [link] [link] 281%29.pdf

Drug Development 108

Drug Development Documentation 108

pharmaphorum

OCTOBER 20, 2020

Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Therefore, the NHC requests that CMS offer more clarity into exactly how it will exclude QALY-based metrics from analysis of certain evidence in value-based decisions.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

Ramblings of a pharmacist

SEPTEMBER 26, 2023

As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. For example, there’s this white paper by Cardinal Health’s CTO last year claiming that blockchain is the solution to all of the supply chain’s problems.

Communication 105

Communication Pharmaceutical Manufacturing Documentation 105

FDA Law Blog: Biosimilars

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.”

Documentation 67

Documentation 67

Putting Patients First Blog

NOVEMBER 14, 2023

15 The NHC advocates for rigorous, transparent documentation of the medical rationale in such instances to prevent discriminatory practices. Traditional value assessment methods fail communities of color and exacerbate health inequities white paper. nmqf.org/s/Disparities-and-Value-Assesssment-White-Paper.pdf 17 Stoumpos, A.,

Communication 40

Communication Bioethics Hospitals Documentation 40

Pharmaceutical Technology

FEBRUARY 16, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

DECEMBER 15, 2022

In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. It is also essential to evaluate the reliability of the company supplying the ingredient: do they provide sufficient communication and documentation?

Documentation 52

Documentation Compounding Communication Pharmaceutical Companies 52

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.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

Pharmaceutical Technology

DECEMBER 13, 2022

Integrated logistics and quality data is documented automatically, and operators can spend less time chasing status, progress and performance data from multiple sources. Effective data sharing can enable the automation of quality documentation, release processes and stability budgets. Challenge 3: Minimising waste.

Vaccines 52

Vaccines Communication Documentation 52

Pharmaceutical Technology

MAY 4, 2023

To find out more about Pall’s specialist filters and the services available in water safety, download the white paper on this page. This document will explain the dangers associated with waterborne bacteria and the importance of a Holistic Water Safety Plan.

Hospitals 52

Hospitals Documentation Communication Immunity 52

Pharmaceutical Technology

APRIL 16, 2023

To learn more, download the document below. model, download this white paper. Through its Maggie family of autoinjectors, SHL is working with its partners to advance the device development side of combination products, together gaining key competitive edges in this burgeoning subcutaneous drug delivery market. References 1.

Documentation 52

Documentation Communication Hospitals 52

Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Free Whitepaper. Precision Medicine: Streamlining Treatments and Drug Development.

Hospitals 52

Hospitals Packaging Medical Schools Documentation 52

Pharmaceutical Technology

MARCH 2, 2023

While not binding, the document covers the regulatory and scientific considerations needed for the development and implementation of continuous manufacturing in pharma, and the guidelines are meant for both new and pre-existing products. Funding was also given to companies that would bolster US-based production of critical medicines.

Documentation 84

Documentation Communication 84