pharmaphorum

AUGUST 31, 2021

However, like many other emerging healthcare technologies, they have been slow to gain traction and there is still confusion and scepticism around ECAs, stemming from a lack of precedence, step-by-step guidance and data to quantify their impact on drug development costs and clinical outcomes.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field. Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.

Documentation 52

Documentation Drug Development 52

pharmaphorum

FEBRUARY 3, 2022

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. Event Hashtag: #SMiPharmaMicroEC.

Documentation 52

Documentation Drug Development 52

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

On July 7, 2023, armed with these new procedures, CDER notified Oncopeptides that it proposed expedited withdrawal of Pepaxto because the postapproval study failed to verify clinical benefit and because Pepaxto was not shown to be safe or effective under its conditions of use (the documents discussed herein are published in the docket here ).

Documentation 59

Documentation Labelling Drug Development 59

Putting Patients First Blog

APRIL 7, 2025

At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

FDA Law Blog: Biosimilars

APRIL 23, 2023

Other challenges in the use of an external control include concerns over potentially important treatment imbalances between arms resulting in biases that were not documented or accounted for. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g.,

Documentation 49

Documentation Drug Development 49

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. Precision Medicine: Streamlining Treatments and Drug Development. Free Whitepaper.

Hospitals 52

Hospitals Packaging Medical Schools Documentation 52

STAT

OCTOBER 28, 2022

One investigator on the study flagged the death, noting it came after the patient experienced bleeding in the brain, and concluded it was related to the drug, according to documents obtained by STAT. Continue to STAT+ to read the full story…

Documentation 299

Documentation Drug Development 299

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

Documentation 108

Documentation Vaccines Drug Development 108

European Pharmaceutical Review

FEBRUARY 1, 2024

What are the top three trends impacting the cardiovascular drug development space today? Even though patients are on these existing therapies that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death.

Documentation 97

Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

JANUARY 18, 2022

Smart device developers. Training device developers. Drug developers. Registrations can be made on the event website at: www.pfsamericas.com/. . Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. Device-safety solution providers. EARLY-BIRD RATES: .

Packaging 52

Packaging Documentation Vaccines Drug Development 52

FDA Law Blog: Biosimilars

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

Drug Development 59

Drug Development Communication Documentation Labelling 59

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., Patient and public perspectives on cell and gene therapies: a systematic review.

Communication 40

Communication Documentation Drug Development 40

Fuld & Company Blog

MARCH 12, 2025

This comprehensive resource provides a detailed calendar of key healthcare conferences happening across the US and Europe in 2025, all in a single, easy-to-access document. Whats inside?

Documentation 52

Documentation Drug Development 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

Express Pharma

DECEMBER 31, 2024

2] Collecting, analysing, and implementing data effectively will be vital for pharma companies to manage competition and market volatility [3] As a regulated, conservative industry archival of documents in the pharma sector is very significant. Technology can bring in better efficiencies to our current systems [4] India Pharma Inc.

Research Laboratories 52

Research Laboratories Documentation Drug Development 52

Express Pharma

OCTOBER 31, 2024

She highlighted that while the GCC was initially set up for cost savings in drug development, the focus has shifted to harnessing India’s vast talent pool, particularly in the scientific and medical fields, in an interview with Viveka Roychowdhury India seems to have become a hub for pharma GCCs. With a long gestation period.

Drug Development 105

Drug Development Hospitals Process Improvement Documentation 105

FDA Law Blog: Biosimilars

JANUARY 30, 2025

Additionally, the January 2025 draft guidance provides that sponsors should propose early benchmarks to assist FDA in its determination of whether a study is underway, which may include recruitment goals, extent of site activation, and proportion of primary endpoint events accrued.

Drug Development 105

Drug Development Documentation 105