pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. billion by 2028. billion in sales in 2028. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals 111

Hospitals Documentation 111

European Pharmaceutical Review

DECEMBER 19, 2023

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

Packaging 105

Packaging Documentation 105

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”. 1 and go into effect in 2026.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

Express Pharma

FEBRUARY 25, 2025

billion by 2028, the challenge lies in achieving widespread implementation across the industry. AI is also reshaping the regulatory landscape by automating document analysis, streamlining submissions for regulatory approval, and monitoring compliance. With the AI market in pharmaceuticals projected to reach US$16.49

Documentation 93

Documentation 93

FDA Law Blog: Biosimilars

JANUARY 2, 2025

Recognizing that the final rule redefining the term healthy is a significant change from FDAs previous approach (in effect for thirty years), FDA plans to issue guidance documents intended to help industry understand the rule and how to work with FGEs. The compliance date is February 25, 2028.

Labelling 52

Labelling Documentation 52

Pharmaceutical Technology

APRIL 27, 2023

billion by 2028. Regulatory documentation including a materials traceability report is provided and an extractables report is available upon request. Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022.

Vaccines 52

Vaccines Drug Development Documentation Communication 52

Putting Patients First Blog

FEBRUARY 11, 2025

CMS should also work directly with providers to minimize administrative burdens caused by risk adjustment changes, as increased documentation requirements could further strain providers, particularly those treating high-cost populations. Equally critical is clear and accessible communication with beneficiaries. 3 American Medical Association.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Communication Documentation Hospitals 52